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Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy Volunteers
The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA 3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4 different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of standard levodopa 100 mg/carbidopa 25 mg (Sinemet® 25/100) in adult male and female healthy volunteers.
Details
| Lead sponsor | Bial - Portela C S.A. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 19 |
| Start date | 2001-04 |
| Completion | 2001-07 |
Conditions
- Parkinson's Disease
Interventions
- BIA 3-202
- Placebo
- Sinemet 25/100
Primary outcomes
- Maximum observed plasma concentration (Cmax) — pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18 and 24 h post-dose
- Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) — pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18 and 24 h post-dose
- Apparent terminal elimination half-life (t1/2) — pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18 and 24 h post-dose
Countries
Portugal