Conditions: Pain
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 61
Healthy volunteers: no

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.

Arms:
arm 1: Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting arm 2: Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting arm 3: Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting arm 4: Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning

Interventions: intervention 1: Oxycodone hydrochloride
Intervention descriptions: intervention 1: 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.

Protocol document: