Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mundipharma

ClinicalTrials.gov Identifier:

NCT01482936

First received: November 17, 2011

Last updated: August 27, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2011

Last Updated Date

August 27, 2012

Start Date ^ICMJE

May 2010

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Area under the plasma concentration(AUC)of drug oxycodone hydrochloride injection at the time frames:predose,0min,2min,5min,10min,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post dose. [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Plasma concentrations of oxycodone and , Noroxycodone and Oxymorphone will be analyzed to determine it.

Original Primary Outcome Measures ^ICMJE

Cmax [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Plasma concentrations of oxycodone and , Noroxycodone and Oxymorphone will be analyzed to determine it.

Change History

Complete list of historical versions of study NCT01482936 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Oxycodone

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.

Study Arm (s)

Experimental: OxyNorm® Injections

Intervention: Drug: Oxycodone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

30 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01482936

Other Study ID Numbers ^ICMJE

OXYI09-CN-101

Has Data Monitoring Committee

Responsible Party

Mundipharma

Study Sponsor ^ICMJE

Mundipharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Mundipharma China Ltd.

Information Provided By

Mundipharma

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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