Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier:
NCT01482936
First received: November 17, 2011
Last updated: August 27, 2012
Last verified: April 2012

November 17, 2011
August 27, 2012
May 2010
April 2011   (final data collection date for primary outcome measure)
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.
Cmax [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Plasma concentrations of oxycodone and , Noroxycodone and Oxymorphone will be analyzed to determine it.
Complete list of historical versions of study NCT01482936 on ClinicalTrials.gov Archive Site
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Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient
A Single Dose PK Study of Oxycodone Hydrochloride Injection 2.5, 5, and 10mg in Chinese Patients With Cancer Pain or Post-operation Patients

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
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.
Experimental: OxyNorm® Injections
Intervention: Drug: Oxycodone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
Not Provided
April 2011   (final data collection date for primary outcome measure)

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.
Both
30 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01482936
OXYI09-CN-101
No
Mundipharma Pte Ltd.
Mundipharma Pte Ltd.
Not Provided
Study Chair: Mundipharma China Ltd. Mundipharma China Ltd.
Mundipharma Pte Ltd.
April 2012

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