Clinical trial NCT01482936: Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2011-12-01
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 10mg.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site: Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army
Study officials:
affiliation: Mundipharma China Ltd.
name: Mundipharma China Ltd.
role: STUDY_CHAIR
References: