OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study

NCT01643772 | Completed Phase 1 Results

• 1 other identifier: OXYC09-CN-102
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with pain.It will be a single center, open label, randomized, oral administration study.

Conditions

Pain

Outcome Measures

Primary Outcomes (16)

• AUC0-t and AUC0-∞ for Participants Who Received a Single Dose

  To calculate AUC0-t AUC0-∞of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method.Plasma concentrations of Oxycodone Hydrochloride single dose 5mg,10mg,20mg will be analyzed.

  blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

• Cmax,Clast for Participants Who Received a Single Dose

  To calculate Cmax,Clast of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

  blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

• Tmax,t1/2 for Participants Who Received a Single Dose

  To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

  blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

• Clearance Rate for Participants Who Received a Single Dose

  To calculate CL of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

  blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

• Vd for Participants Who Received a Single Dose

  To calculate Apparent Distribution Volume (Vd) Vd of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

  blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

• ke for Participants Who Received a Single Dose

  To calculate Terminal Elimination Rate (ke) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

  blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

• AUCss for Participants Who Received Multiple Dose

  To calculate AUCss of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

  Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

• Css_min,Css_max and Css_av for Participants Who Received Multiple Dose

  To calculate Css\_min,Css\_max and Css\_av of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

  Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

• Tmax,t1/2 for Participants Who Received Multiple Dose

  To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

  Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

• CL for Participants Who Received Multiple Dose

  To calculate Clearance rate (CL) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

  Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

• Fluctuation Index (DF) for Participants Who Received Multiple Dose

  To calculate Fluctuation index (DF) of Drug Valley and Peak Concentration of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

  Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

• The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

  The excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.

  Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h

• Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

  Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.

  post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h

• Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

  Average cumulative excretion rate of drugs were calculated according to the concentration and volume of drugs in urine after single dose.

  post dose 24h

• The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)

  The excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day.

  Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day

• Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)

  Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day .

  post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day

Study Arms (4)

Oxycodone Hydrochloride 5 mg Capsules

EXPERIMENTAL

Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting

Drug: Oxycodone hydrochloride

Oxycodone Hydrochloride 10 mg Capsules

EXPERIMENTAL

Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting

Drug: Oxycodone hydrochloride

Oxycodone Hydrochloride 20 mg Capsules

EXPERIMENTAL

Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting

Drug: Oxycodone hydrochloride

Oxycodone Hydrochloride 10 mg Capsules(multi-dose)

EXPERIMENTAL

Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning

Drug: Oxycodone hydrochloride

Interventions

Oxycodone hydrochloride DRUG

The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.

Also known as: OxyNorm® Capsules

Oxycodone Hydrochloride 10 mg Capsules; Oxycodone Hydrochloride 10 mg Capsules(multi-dose); Oxycodone Hydrochloride 20 mg Capsules; Oxycodone Hydrochloride 5 mg Capsules

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with pain, Multiple dose group should enroll the Patients with cancer pain;
• Patients aged \>≥30 to ≤ 60 years;
• Body weight ≥ 45kg, and BMI range ≥19, \<24;
• Karnofsky score ≥ 70;
• The results of liver function and kidney tests must meet the following criteria: ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr is within the upper limit of normal value ranges by a factor 1.25;
• The electrocardiogram examination results are normal;
• Patients must have given a written informed consent prior to this trial, and have the capability to complete every required test.

You may not qualify if:

• Have hypersensitivity history to any opioids;
• Have known hypersensitivity to any of compositions of the study drugs;
• Patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region；
• Patients with respiratory depression, cor pulmonale, or chronic bronchial asthma;
• Patients who are unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal;
• Patients with hypercarbia;
• Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency;
• Patients with alcoholism or drug abuse history;
• Positive anti-HIV or syphilis antibody test result;
• Patients who are pregnant, or lactating;
• Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids;
• Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within one month prior to the start of the study;
• Subjects who participated in a clinical research study within one month of study entry;
• Patients who are currently taking opioids.

Sponsors & Collaborators

• Mundipharma (China) Pharmaceutical Co. Ltd: lead

Study Sites (1)

Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army

Beijing, China

Location

MeSH Terms

Conditions

Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Ms. Dan Zhu, Clinical operation and quality lead of the study
• Organization: Mundipharma (China) Pharmaceutical Co.Ltd

dan.zhu@mundipharma.com.cn

+8610 6563 6891

Study Officials

• Mundipharma China Ltd.

  Mundipharma China Ltd.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: July 18, 2012
• Study Start: May 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-09

Locations

CN (1)