Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient

NCT01482936 | Completed Phase 1

• 1 other identifier: OXYI09-CN-101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, open label, randomized, parallel group single dose intravenous (i.v.) administration study. The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) concentrations of oxycodone hydrochloride injection at various time points: predose, 0min, 2min, 5min, 10min, 15min, 30min, 45min, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24hr post dose.

  Plasma concentrations of oxycodone and Noroxycodone and Oxymorphone will be analyzed.

  2 days

Study Arms (1)

Oxycodone (OxyNorm®) Injection

EXPERIMENTAL

The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg

Drug: Oxycodone (OxyNorm®) Injection

Interventions

Oxycodone (OxyNorm®) Injection DRUG

The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg.The plasma concentration will be analyzed to determine the following pharmacokinetic parameters:AUC0-t:ug•hr/L-Area under the plasma concentration-time curve frame: predose,0,2min,5min,10min,15min,30min,45min,1hr,1.5hr,2hr,3hr,4hr,6hr,8hr,12hr, 24hr post-dose.AUC0-inf:ug•hr/L-Area under the plasma concentration-time curve extrapolated to infinity. Cmax: ug/L-Maximum observed plasma concentration of oxycodone and noroxycodone.Tmax: hrs-time at which Cmax is first observed. t½: Apparent half life of oxycodone elimination.

Also known as: OxyNorm®

Oxycodone (OxyNorm®) Injection

Eligibility Criteria

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

You may qualify if:

• Patients with tumor pain / postoperative pain, or subjects with pain caused by other diseases;
• Patients aged \>30 to ≤ 60 years;
• Body weight ≥ 45kg, and BMI range ≥19, \<24;
• Karnofsky score ≥ 70;
• Expected survival is above 3 months;
• 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 pulmonary, or chronic bronchial asthma;
• Patient 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 ant-HIV or syphilis antibody test result;
• Urine screening before study is positive for the 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 two months of study entry.
• Patients who are currently taking opioids.

Sponsors & Collaborators

• Mundipharma (China) Pharmaceutical Co. Ltd: lead

Study Sites (1)

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

Beijing, China

Location

MeSH Terms

Conditions

Pain

Interventions

Oxycodone; Injections

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; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mundipharma China Ltd.

  Mundipharma China Ltd.

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: December 1, 2011
• Study Start: May 1, 2010
• Primary Completion: April 1, 2011
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

CN (1)