OTR Tablet 40 mg Fed-state Bioequivalence Study

Status Completed

Clinical Trial Summary

An open-label, single dose, randomized, cross-over study to confirm the bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fed state in Chinese subjects with chronic pain.

Clinical Trial Description

The investigation is designed as an open-label, single dose, randomized, and cross-over study to determine the pharmacokinetics(PK) profile of oxycodone from OTR tablet 40 mg and OXYCONTIN tablet 40 mg in Chinese subjects with chronic pain in a fed stat.

Subjects with histories of chronic pain are chosen as the target population. Inclusion/exclusion criteria are strictly defined to reduce the potential variation of the PK data. ;

Study Design

Related Conditions & MeSH terms

Chronic Pain

Clinical Trial Details

NCT number	NCT03398330
Study type	Interventional
Source	Mundipharma (China) Pharmaceutical Co. Ltd
Contact
Status	Completed
Phase	Phase 1
Start date	March 16, 2017
Completion date	November 6, 2017

View Details

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