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Clinical Trials/NCT00460785
NCT00460785CompletedPhase 1

Phase 1 Single Center Trial to Demonstrate the Bioequivalence of a New Combination Analgesic Formulation as Compared to an Equimolar Marketed Formulation

Grünenthal GmbH0 sites32 target enrollmentStarted: February 1, 2007Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
32
Primary Endpoint
Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
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

Outcomes

Primary Outcomes

Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.

Secondary Outcomes

  • Descriptive, e. g. safety/tolerability of Test comparable to Reference

Investigators

Sponsor Class
Industry

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