Bioequivalence Trial of a New Opioid Combination Compared to Reference

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Standard Phase I
Cyp 2D6 extensive metabolizers

Exclusion criteria

Standard Phase I
Contraindications of current reference tablet SmPC

Treatment and study plan

Opioid

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Grünenthal GmbH

Industry

Registry information

Official study title

Phase 1 Single Center Trial to Demonstrate the Bioequivalence of a New Combination Analgesic Formulation as Compared to an Equimolar Marketed Formulation

Important dates

Study start: 2007
Study completion: 2007
First posted: Apr 16, 2007
Registry last updated: Jul 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed