Bioequivalence Trial of a New Opioid Combination Compared to Reference

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00460785
Recruitment Status : Completed
First Posted : April 16, 2007
Last Update Posted : July 6, 2007
Information provided by:
Grünenthal GmbH

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Opioid Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2007
Actual Study Completion Date : March 2007

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00460785

Sponsors and Collaborators
Grünenthal GmbH
Principal Investigator: Wolfgang Timmer, Dr. CRS Mannheim Identifier: NCT00460785     History of Changes
Other Study ID Numbers: 544506
First Posted: April 16, 2007    Key Record Dates
Last Update Posted: July 6, 2007
Last Verified: March 2007

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents