Title

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

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    fentanyl ...
  • Study Participants

    32
The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference
Study Started
Feb 28
2007
Study Completion
Mar 31
2007
Last Update
Jul 06
2007
Estimate

Drug Opioid

Criteria

Inclusion Criteria:

Standard Phase I
Cyp 2D6 extensive metabolizers

Exclusion Criteria:

Standard Phase I
Contraindications of current reference tablet SmPC
No Results Posted