OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study

NCT ID: NCT01643772

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-07-31

Brief Summary

A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with pain.It will be a single center, open label, randomized, oral administration study.

Detailed Description

Single dose: The subjects will be randomized to receive a single dose of OxyNorm® immediate-release capsules 5, 10, and 20mg.

Multiple dose: The subjects will take 3 days OxyNorm® capsule 10mg, once every 6 hours, 10mg per dose. In the morning of the 4th day, the subjects will take single dose of OxyNorm® capsule 10mg. On the 5th day, all the subjects complete the study.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxycodone Hydrochloride 5 mg Capsules

Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting

Group Type: EXPERIMENTAL

Oxycodone hydrochloride

Intervention Type: DRUG

The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.

Oxycodone Hydrochloride 10 mg Capsules

Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting

Group Type: EXPERIMENTAL

Oxycodone hydrochloride

Intervention Type: DRUG

The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.

Oxycodone Hydrochloride 20 mg Capsules

Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting

Group Type: EXPERIMENTAL

Oxycodone hydrochloride

Intervention Type: DRUG

The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.

Oxycodone Hydrochloride 10 mg Capsules(multi-dose)

Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning

Group Type: EXPERIMENTAL

Oxycodone hydrochloride

Intervention Type: DRUG

The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.

Interventions

Oxycodone hydrochloride

The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.

Intervention Type: DRUG

Other Intervention Names

OxyNorm® Capsules

Eligibility Criteria

Inclusion Criteria

• Patients with pain, Multiple dose group should enroll the Patients with cancer pain;
• Patients aged >≥30 to ≤ 60 years;
• Body weight ≥ 45kg, and BMI range ≥19, <24;
• Karnofsky score ≥ 70;
• 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 pulmonale, or chronic bronchial asthma;
• Patients who are 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 anti-HIV or syphilis antibody test result;
• Patients who are pregnant, or lactating;
• Urine screening before study is positive for 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 one month of study entry;
• Patients who are currently taking opioids.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma (China) Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mundipharma China Ltd.

Role: STUDY_CHAIR

Mundipharma China Ltd.

Locations

Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army

Beijing, , China

Countries

China

Other Identifiers

OXYC09-CN-102

Identifier Type: -

Identifier Source: org_study_id