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

Mundipharma

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Oxycodone hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01643772

OXYC09-CN-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 4 patient groups

Oxycodone Hydrochloride 5 mg Capsules

Experimental group

Description:

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

Treatment:

Drug: Oxycodone hydrochloride

Oxycodone Hydrochloride 10 mg Capsules

Experimental group

Description:

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

Treatment:

Drug: Oxycodone hydrochloride

Oxycodone Hydrochloride 20 mg Capsules

Experimental group

Description:

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

Treatment:

Drug: Oxycodone hydrochloride

Oxycodone Hydrochloride 10 mg Capsules(multi-dose)

Experimental group

Description:

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

Treatment:

Drug: Oxycodone hydrochloride