drugset / Trial / NCT03099226

Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Dose Regimens of BIA 5-453

NCT03099226 ↗

Phase 1 Completed 23 enrolled Bial - Portela C S.A.
RandomizedSequentialDouble-blindTreatment

Summary

The purpose of this study was to characterise the plasma and urine pharmacokinetic profile of Etamicastat (BIA 5-453) and its metabolites after three multiple rising dose regimens of Etamicastat (BIA 5-453).

Timeline

Start
2008-07-15
Primary completion
2009-04-03
Completion
2009-04-03

Drugs

EvaluationDrugModalityDoseRoute
Subject BIA 5-453 Unknown 50 mg —
Subject BIA 5-453 Unknown 100 mg —
Subject BIA 5-453 Unknown 200 mg —

Indications