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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
  Purpose

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


Condition Intervention Phase
Healthy
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
  Eligibility

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

Inclusion Criteria:

  • Standard Phase I
  • Cyp 2D6 extensive metabolizers

Exclusion Criteria:

  • Standard Phase I
  • Contraindications of current reference tablet SmPC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460785

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

No publications provided

ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on November 25, 2014