Status:

COMPLETED

Bioequivalence Trial of a New Opioid Combination Compared to Reference

Lead Sponsor:

Grünenthal GmbH

Conditions:

Healthy

Eligibility:

MALE

18-45 years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • Standard Phase I
  • Cyp 2D6 extensive metabolizers

Exclusion

  • Standard Phase I
  • Contraindications of current reference tablet SmPC

Key Trial Info

Start Date :

February 1 2007

Trial Type :

INTERVENTIONAL

End Date :

March 1 2007

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT00460785

Start Date

February 1 2007

End Date

March 1 2007

Last Update

July 6 2007

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