Bioequivalence Trial of a New Opioid Combination Compared to Reference
Sponsor
Grünenthal GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT00460785
Collaborator
(none)
32
28
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
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
Study Start Date
:
Feb 1, 2007
Actual Study Completion Date
:
Mar 1, 2007
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Standard Phase I
-
Cyp 2D6 extensive metabolizers
Exclusion Criteria:
-
Standard Phase I
-
Contraindications of current reference tablet SmPC
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Grünenthal GmbH
Investigators
- Principal Investigator: Wolfgang Timmer, Dr., CRS Mannheim
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00460785
Other Study ID Numbers:
- 544506
First Posted:
Apr 16, 2007
Last Update Posted:
Jul 6, 2007
Last Verified:
Mar 1, 2007
Additional relevant MeSH terms: