NCT01643772

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

OxyNorm® Capsules (Immediate-Release) PK Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-07-18
• Last updated: 2019-10-21
• Results posted: 2019-10-21

Locations

1 site across 1 country: China