OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Oxycodone Hydrochloride	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	OxyNorm® Capsules (Immediate-Release) PK Study

Further study details as provided by Mundipharma Pte Ltd.:

Primary Outcome Measures:

Area under curve(AUC) [ Time Frame: predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose. ] [ Designated as safety issue: Yes ]
To investigate the pharmacokinetic profile, dose-proportionality, and evaluate drug accumulation of Oxycodone Hydrochloride after single dose of OxyNorm® capsules.
Area Under Curve(AUC) of time frame for Multi-dose: 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. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
To investigate the pharmacokinetic profile, dose-proportionality, and evaluate drug accumulation of Oxycodone Hydrochloride after multiple dose of OxyNorm® capsules.


Enrollment:	61
Study Start Date:	May 2011
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: OxyNorm® Capsules	Drug: Oxycodone Hydrochloride 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. Other Name: No other name

Detailed Description:

Single dose: The subjects will be randomized to receive a single dose of OxyNorm® immediate-release capsules 5, 10, and 20mg.

Multiple dose: The subjects will take 3 days OxyNorm® capsule 10mg, once every 6 hours, 10mg per dose. In the morning of the 4th day, the subjects will take single dose of OxyNorm® capsule 10mg. On the 5th day, all the subjects complete the study.

Eligibility


Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

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 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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643772

Locations


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

Sponsors and Collaborators

Mundipharma Pte Ltd.

Investigators


Study Chair:	Mundipharma China Ltd.	Mundipharma China Ltd.

More Information

No publications provided


Responsible Party:	Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier:	NCT01643772 History of Changes
Other Study ID Numbers:	OXYC09-CN-102
Study First Received:	November 17, 2011
Last Updated:	June 24, 2013
Health Authority:	China: Food and Drug Administration

ClinicalTrials.gov processed this record on March 03, 2015