OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients

NCT02880475 | Completed Phase 1 Results

• 1 other identifier: OXN08-CN-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomized, single-dose, parallel group study. The objectives of this study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN) prolonged release (PR) tablet 5/2.5 mg (OXN 5/2.5) and 20/10 mg (OXN 20/10) in Chinese patients with moderate to severe chronic non-malignant pain.

Conditions

Chronic Pain

Keywords

Moderate to severe chronic non-malignant pain

Outcome Measures

Primary Outcomes (64)

• AUC0-48hr of Noroxycodone Plasma Concentration.

  AUC0-48hr of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.

• AUC0-t of Noroxycodone Plasma Concentration

  AUC0-t of Noroxycodone plasma concentration.Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed .(If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis. )

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.

• AUC_%Extrap of Noroxycodone Plasma Concentration

  AUC\_%Extrap of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUCinf of Noroxycodone Plasma Concentration

  AUCinf of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Cmax of Noroxycodone Plasma Concentration

  Cmax of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Lambda_z of Noroxycodone Plasma Concentration

  Lambda\_z of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• T1/2 of Noroxycodone Plasma Concentration

  T1/2 of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Tmax of Noroxycodone Plasma Concentration

  Tmax of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-48hr of Noroxymorphone Plasma Concentration

  AUC0-48hr of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-t of Noroxymorphone Plasma Concentration

  AUC0-t of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC_%Extrap of Noroxymorphone Plasma Concentration

  AUC\_%Extrap of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUCinf of Noroxymorphone Plasma Concentration

  AUCinf of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Cmax of Noroxymorphone Plasma Concentration

  Cmax of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Lambda_z of Noroxymorphone Plasma Concentration

  Lambda\_z of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• T1/2 of Noroxymorphone Plasma Concentration

  T1/2 of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Tmax of Noroxymorphone Plasma Concentration

  Tmax of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-48hr of Oxycodone Plasma Concentration

  AUC0-48hr of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-t of Oxycodone Plasma Concentration

  AUC0-t of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC_%Extrap of Oxycodone Plasma Concentration

  AUC\_%Extrap of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUCinf of Oxycodone Plasma Concentration

  AUCinf of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Cmax of Oxycodone Plasma Concentration

  Cmax of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Lambda_z of Oxycodone Plasma Concentration

  Lambda\_z of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• T1/2 of Oxycodone Plasma Concentration

  T1/2 of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Tmax of Oxycodone Plasma Concentration

  Tmax of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-48hr of Oxymorphone Plasma Concentration

  AUC0-48hr of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-t of Oxymorphone Plasma Concentration

  AUC0-t of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC_%Extrap of Oxymorphone Plasma Concentration

  AUC\_%Extrap of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUCinf of Oxymorphone Plasma Concentration

  AUCinf of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Cmax of Oxymorphone Plasma Concentration

  Cmax of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Lambda_z of Oxymorphone Plasma Concentration

  Lambda\_z of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• T1/2 of Oxymorphone Plasma Concentration

  T1/2 of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Tmax of Oxymorphone Plasma Concentration

  Tmax of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-48hr of 6-B-Naloxol Plasma Concentration

  AUC0-48hr of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-t of 6-B-Naloxol Plasma Concentration

  AUC0-t of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC_%Extrap of 6-B-Naloxol Plasma Concentration

  AUC\_%Extrap of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUCinf of 6-B-Naloxol Plasma Concentration

  AUCinf of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Cmax of 6-B-Naloxol Plasma Concentration

  Cmax of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Lambda_z of 6-B-Naloxol Plasma Concentration

  Lambda\_z of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• T1/2 of 6-B-Naloxol Plasma Concentration

  T1/2 of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Tmax of 6-B-Naloxol Plasma Concentration

  Tmax of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-48hr of NLLG Plasma Concentration

  AUC0-48hr of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-t of NLLG Plasma Concentration

  AUC0-t of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC_%Extrap of NLLG Plasma Concentration

  AUC\_%Extrap of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUCinf of NLLG Plasma Concentration

  AUCinf of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Cmax of NLLG Plasma Concentration

  Cmax of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Lambda_z of NLLG Plasma Concentration

  Lambda\_z of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• T1/2 of NLLG Plasma Concentration

  T1/2 of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Tmax of NLLG Plasma Concentration

  Tmax of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-48hr of NLXG Plasma Concentration

  AUC0-48hr of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-t of NLXG Plasma Concentration

  AUC0-t of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC_%Extrap of NLXG Plasma Concentration

  AUC\_%Extrap of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUCinf of NLXG Plasma Concentration

  AUCinf of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Cmax of NLXG Plasma Concentration

  Cmax of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Lambda_z of NLXG Plasma Concentration

  Lambda\_z of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• T1/2 of NLXG Plasma Concentration

  T1/2 of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Tmax of NLXG Plasma Concentration

  Tmax of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-48hr of Naloxone Plasma Concentration

  AUC0-48hr of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC0-t of Naloxone Plasma Concentration

  AUC0-t of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUC_%Extrap of Naloxone Plasma Concentration

  AUC\_%Extrap of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• AUCinf of Naloxone Plasma Concentration

  AUCinf of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Cmax of Naloxone Plasma Concentration

  Cmax of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Lambda_z of Naloxone Plasma Concentration

  Lambda\_z of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• T1/2 of Naloxone Plasma Concentration

  T1/2 of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

• Tmax of Naloxone Plasma Concentration

  Tmax of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

  Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.

Study Arms (2)

OXN prolonged release tablet 5/2.5mg

EXPERIMENTAL

The subjects were randomized to receive a single dose of OXN prolonged release tablet 5/2.5mg for one time.

Drug: OXN PR tablet

OXN prolonged release tablet 20/10mg

EXPERIMENTAL

The subjects were randomized to receive a single dose of OXN prolonged release tablet 20/10 mg for one time.

Drug: OXN PR tablet

Interventions

OXN PR tablet DRUG

Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg

Also known as: Targin

OXN prolonged release tablet 20/10mg; OXN prolonged release tablet 5/2.5mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Chinese patients with moderate to severe chronic non-malignant pain.
• Male and female subjects with age range 18 to 65 years (including 18 and 65), body weight ≥ 45kg and BMI range 18 to 30 (including 18 and 30).
• Patients who should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale.
• Patients, who are able to read, understand and sign written informed consent prior to study participation and are willing to follow the protocol requirements.
• Females of childbearing potential and less than one year post-menopausal must have a negative serum pregnancy test during screening visit and at check-in and be non-lactating. In addition, they must be willing to use adequate and reliable contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (intrauterine Device, hormonal), sexual abstinence or vasectomised partner.

You may not qualify if:

• Females who are pregnant (positive β-human chorionic gonadotrophin \[HCG\] test) or lactating.
• Use of opioid or opioid antagonist-containing medication in the 30 days before the start of the study.
• Known sensitivity to oxycodone, naloxone, or related compounds.
• Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention (medication or surgical) or renal artery stenosis, or any other medical condition, that, in the opinion of the investigator or the sub-investigator, precludes entry into this study.
• Subject who have a past (within 5 years) history of malignant neoplasm including leukemia and lymphoma.
• The electrocardiogram examination results are abnormal, in the opinion of the investigator or the sub-investigator, and are clinical significance.
• Subjects with abnormal liver function (values exceed the upper limit of normal for AST, ALT or total bilirubin during the Screening Period) or abnormal renal function (values exceed the upper limit of normal for serum creatinine during the Screening Period).
• Patients with a contraindication to the study medication.
• Subjects who have a psychiatric disorder such that participation in the study may, in the opinion of the investigator or the sub-investigator, pose an unacceptable risk to the subject.
• Subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the Screening Period, or subjects who, in the opinion of the investigator or the sub-investigator, have demonstrated addictive or substance abuse behaviors.
• Subjects with uncontrolled seizures or convulsive disorder.
• Subjects who will receive any interventional therapy (surgery, paracentesis,etc) for arthritis during the study period.
• History of or any current conditions that might have interfered with drug absorption, distribution, metabolism or excretion.
• Any history of frequent nausea or emesis regardless of aetiology.
• Participation in any clinical drug study during the 3 months preceding the initial dose in this study.

Sponsors & Collaborators

• Mundipharma (China) Pharmaceutical Co. Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Junjiao Ma
• Organization: Mundipharma (China) Pharmaceutical Co. , Ltd

Junjiao.Ma@mundipharma.com.cn

01065636711

Study Officials

• Victoria YU

  Mundipharma (China) Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 26, 2016
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 10, 2015
• Last Updated: July 17, 2019
• Results First Posted: July 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)