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OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study

This study is currently recruiting participants.
Verified April 2012 by Mundipharma
Sponsor:
Information provided by (Responsible Party):
Mundipharma
ClinicalTrials.gov Identifier:
NCT01643772
First received: November 17, 2011
Last updated: July 17, 2012
Last verified: April 2012
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mundipharma:

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.


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: July 2012
Estimated 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, corpulmonale, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643772

Contacts
Contact: Mundipharma China Ltd. +86 10 65636800

Locations
China
Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army Recruiting
Beijing, China
Contact: Mundipharma China Ltd.     ＋86 10 65636800        
Principal Investigator: Mundipharma China Ltd. Ltd.            
Sponsors and Collaborators
Mundipharma
Investigators
Study Chair: Mundipharma China Ltd. Mundipharma China Ltd.
  More Information

No publications provided

Responsible Party: Mundipharma
ClinicalTrials.gov Identifier: NCT01643772     History of Changes
Other Study ID Numbers: OXYC09-CN-102
Study First Received: November 17, 2011
Last Updated: July 17, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on June 18, 2013