Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482936
• Other study ID #: OXYI09-CN-101
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2011
• Last updated: August 10, 2015
• Start date: May 2010

Study information

• Verified date: August 2015
• Source: Mundipharma (China) Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
China	Investigational Site: Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma (China) Pharmaceutical Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes