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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
  Purpose

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.


Condition Intervention Phase
Pain
 Drug: Oxycodone
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mundipharma:

Primary Outcome Measures:
  • 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.


Enrollment: 44
Study Start Date: May 2010
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OxyNorm® Injections 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.

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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482936

Locations
China
Investigational Site: Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army
Beijing, China
Sponsors and Collaborators
Mundipharma
Investigators
Study Chair: Mundipharma China Ltd. Mundipharma China Ltd.
  More Information

No publications provided

Responsible Party: Mundipharma
ClinicalTrials.gov Identifier: NCT01482936     History of Changes
Other Study ID Numbers: OXYI09-CN-101
Study First Received: November 17, 2011
Last Updated: August 27, 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 May 22, 2013