Bioequivalence Trial of a New Opioid Combination Compared to Reference

This study has been completed.
Information provided by:
Grünenthal GmbH Identifier:
First received: March 28, 2007
Last updated: July 5, 2007
Last verified: March 2007
The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference

Condition Intervention Phase
Drug: Opioid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Single Center Trial to Demonstrate the Bioequivalence of a New Combination Analgesic Formulation as Compared to an Equimolar Marketed Formulation

Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:
  • Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.

Secondary Outcome Measures:
  • Descriptive, e. g. safety/tolerability of Test comparable to Reference

Estimated Enrollment: 32
Study Start Date: February 2007
Study Completion Date: March 2007

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Standard Phase I
  • Cyp 2D6 extensive metabolizers

Exclusion Criteria:

  • Standard Phase I
  • Contraindications of current reference tablet SmPC
  Contacts and Locations
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Please refer to this study by its identifier: NCT00460785

Sponsors and Collaborators
Grünenthal GmbH
Principal Investigator: Wolfgang Timmer, Dr. CRS Mannheim
  More Information

No publications provided Identifier: NCT00460785     History of Changes
Other Study ID Numbers: 544506 
Study First Received: March 28, 2007
Last Updated: July 5, 2007
Health Authority: Germany: Ethics Commission processed this record on February 08, 2016