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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 Nebicapone Small molecule 50 mg Oral
Subject Nebicapone Small molecule 100 mg Oral
Subject Nebicapone Small molecule 200 mg Oral
Subject Nebicapone Small molecule 300 mg Oral
Subject Nebicapone Small molecule 400 mg Oral
Background Levodopa Small molecule 100 mg Oral
Background benserazide Small molecule 25 mg Oral

Indications

Parkinson disease