Bioequivalence Trial of a New Opioid Combination Compared to Reference
July 5, 2007 updated by: Grünenthal GmbH
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
Study Overview
Study Type
Interventional
Enrollment
32
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Standard Phase I
- Cyp 2D6 extensive metabolizers
Exclusion Criteria:
- Standard Phase I
- Contraindications of current reference tablet SmPC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.
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Secondary Outcome Measures
Outcome Measure |
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Descriptive, e. g. safety/tolerability of Test comparable to Reference
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wolfgang Timmer, Dr., CRS Mannheim
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
March 28, 2007
First Submitted That Met QC Criteria
April 13, 2007
First Posted (Estimate)
April 16, 2007
Study Record Updates
Last Update Posted (Estimate)
July 6, 2007
Last Update Submitted That Met QC Criteria
July 5, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 544506
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.