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 1Lead Sponsor
GrunenthalStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HealthyIntervention/Treatment
fentanyl ...Study Participants
32The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference
Inclusion Criteria: Standard Phase I Cyp 2D6 extensive metabolizers Exclusion Criteria: Standard Phase I Contraindications of current reference tablet SmPC