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Bioequivalence Trial of a New Opioid Combination Compared to Reference

This study has been completed.
Sponsor:
Information provided by:
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT00460785
First received: March 28, 2007
Last updated: July 5, 2007
Last verified: March 2007

March 28, 2007
July 5, 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
Not Provided
Not Provided
 
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00460785
544506
Not Provided
Not Provided
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