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A Single Dose PK Study of Oxycodone Hydrochloride Injection 2.5, 5, and 10mg in Chinese Patients With Cancer Pain or Post-operation Patients


Phase 1
30 Years
60 Years
Not Enrolling
Both
Pain

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Trial Information

A Single Dose PK Study of Oxycodone Hydrochloride Injection 2.5, 5, and 10mg in Chinese Patients With Cancer Pain or Post-operation Patients


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.


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.

Type of Study:

Interventional

Study Design:

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

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.

Outcome Description:

Plasma concentrations of oxycodone and , Noroxycodone and Oxymorphone will be analyzed to determine it.

Outcome Time Frame:

2 days

Safety Issue:

Yes

Principal Investigator

Mundipharma China Ltd.

Investigator Role:

Study Chair

Investigator Affiliation:

Mundipharma China Ltd.

Authority:

China: Food and Drug Administration

Study ID:

OXYI09-CN-101

NCT ID:

NCT01482936

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Pain

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