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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
  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
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00460785


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

ClinicalTrials.gov Identifier: NCT00460785     History of Changes
Other Study ID Numbers: 544506
First Submitted: March 28, 2007
First Posted: April 16, 2007
Last Update Posted: July 6, 2007
Last Verified: March 2007

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