Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient

A Single Dose PK Study of Oxycodone Hydrochloride Injection 2.5, 5, and 10mg in Chinese Patients With Cancer Pain or Post-operation Patients

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Oxycodone (OxyNorm®) Injection

Detailed Description

After up to 7 days screening period, Eligible Patients will be randomized to 1 of 3 groups, and begin treatment with single dose of OxyNorm® 2.5,5, and 10mg.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Oxycodone (OxyNorm®) Injection; The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg

Drug: Oxycodone (OxyNorm®) Injection; 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.; Other Names: OxyNorm®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): December 1, 2011

Study Record Updates

• Last Update Posted (Estimate): August 11, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: OXYI09-CN-101