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Bioequivalence Trial of a New Opioid Combination Compared to Reference

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00460785
First Posted: April 16, 2007
Last Update Posted: July 6, 2007
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.
Information provided by:
Grünenthal GmbH
March 28, 2007
April 16, 2007
July 6, 2007
February 2007
Not Provided
Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.
Same as current
Complete list of historical versions of study NCT00460785 on ClinicalTrials.gov Archive Site
Descriptive, e. g. safety/tolerability of Test comparable to Reference
Same as current
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Bioequivalence Trial of a New Opioid Combination Compared to Reference
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
Drug: Opioid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
March 2007
Not Provided

Inclusion Criteria:

  • Standard Phase I
  • Cyp 2D6 extensive metabolizers

Exclusion Criteria:

  • Standard Phase I
  • Contraindications of current reference tablet SmPC
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00460785
544506
Not Provided
Not Provided
Not Provided
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Grünenthal GmbH
Not Provided
Principal Investigator: Wolfgang Timmer, Dr. CRS Mannheim
Grünenthal GmbH
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP