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Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy volunteers. In each part, the study consisted of two consecutive single-dose treatment periods separated by a washout period of at least 14 days.
Details
| Lead sponsor | Bial - Portela C S.A. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 85 |
| Start date | 2014-03 |
| Completion | 2014-06 |
Conditions
- Parkinson
Interventions
- BIA 9-1067 (clinical micronized, CM)
- BIA 9-1067 (to-be-marketed, TBM)
Primary outcomes
- Cmax - Maximum Observed Plasma Concentration — before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose