Bioequivalence Trial of a New Opioid Combination Compared to Reference

July 5, 2007 updated by: Grünenthal GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

32

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Standard Phase I
  • Cyp 2D6 extensive metabolizers

Exclusion Criteria:

  • Standard Phase I
  • Contraindications of current reference tablet SmPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grünenthal GmbH

Investigators

  • Principal Investigator: Wolfgang Timmer, Dr., CRS Mannheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

March 28, 2007

First Submitted That Met QC Criteria

April 13, 2007

First Posted (Estimate)

April 16, 2007

Study Record Updates

Last Update Posted (Estimate)

July 6, 2007

Last Update Submitted That Met QC Criteria

July 5, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 544506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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