Bioequivalence Trial of a New Opioid Combination Compared to Reference

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00460785
• Lead Sponsor: Grünenthal GmbH

Brief Summary

The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Status Verified: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2007-03-28
• Study First Submitted QC: 2007-04-13
• Study First Posted: 2007-04-16
• Last Update Submitted: 2007-07-05
• Last Update Posted: 2007-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

• Standard Phase I
• Cyp 2D6 extensive metabolizers

Exclusion Criteria

• Standard Phase I
• Contraindications of current reference tablet SmPC

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.

Secondary Outcome Measures

Name	Time	Method
Descriptive, e. g. safety/tolerability of Test comparable to Reference