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drugset / Trial / NCT02763852

Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg)

NCT02763852 ↗

Phase 1 Completed 18 enrolled Bial - Portela C S.A.
RandomizedCrossoverDouble-blindTreatment

Summary

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/benserazide 25 mg (Madopar® 125) in adult male and female healthy volunteers.

Timeline

Start
2001-04
Primary completion
2001-07
Completion
2001-07

Drugs

EvaluationDrugModalityDoseRoute
Subject BIA 3-202 Unknown 50 mg Oral
Subject BIA 3-202 Unknown 100 mg Oral
Subject BIA 3-202 Unknown 200 mg Oral
Subject BIA 3-202 Unknown 300 mg Oral
Subject BIA 3-202 Unknown 400 mg Oral
Background Levodopa Unknown 100 mg Oral
Background benserazide Small molecule 25 mg Oral

Indications

Parkinson disease