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Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient

This study has been completed.
Information provided by (Responsible Party):
Mundipharma (China) Pharmaceutical Co. Ltd Identifier:
First received: November 17, 2011
Last updated: August 10, 2015
Last verified: August 2015
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
Drug: Oxycodone (OxyNorm®) Injection
Phase 1

Study Type: Interventional
Study Design: 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:

Further study details as provided by Mundipharma (China) Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 days ]
    Plasma concentrations of oxycodone and Noroxycodone and Oxymorphone will be analyzed.

Enrollment: 44
Study Start Date: May 2010
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxycodone (OxyNorm®) Injection
The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg
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.
Other Name: OxyNorm®

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.

Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01482936

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

Responsible Party: Mundipharma (China) Pharmaceutical Co. Ltd Identifier: NCT01482936     History of Changes
Other Study ID Numbers: OXYI09-CN-101
Study First Received: November 17, 2011
Last Updated: August 10, 2015

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 25, 2017