Status:
COMPLETED
Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient
Lead Sponsor:
Mundipharma (China) Pharmaceutical Co. Ltd
Conditions:
Pain
Eligibility:
All Genders
30-60 years
Phase:
PHASE1
Brief Summary
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 10...
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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01482936
Start Date
May 1 2010
Last Update
August 11 2015
Active Locations (1)
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1
Investigational Site: Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army
Beijing, China