drugset / Trial / NCT03097211

Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg

NCT03097211

Phase 1 Completed 38 enrolled Bial - Portela C S.A.
RandomizedSequentialDouble-blindTreatment

Summary

The purpose of this study was to determine whether the administration of BIA 6-512 (25 mg, 50 mg, 75 mg and 100 mg) at steady-state affects the pharmacokinetics of levodopa when administered in combination with a single-dose of immediate release levodopa/benserazide 200/50 mg or with a single-dose of immediate release levodopa/benserazide 200/50 mg plus a single-dose of nebicapone 150 mg.

Timeline

Start
2006-07-17
Primary completion
2006-10-20
Completion
2006-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Levodopa Small molecule 200 mg Oral
Subject Resveratrol Small molecule 25 mg Oral
Subject Resveratrol Small molecule 50 mg Oral
Subject Resveratrol Small molecule 75 mg Oral
Subject Resveratrol Small molecule 100 mg Oral
Background Nebicapone Small molecule 150 mg Oral
Background benserazide Small molecule 50 mg Oral

Indications