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drugset / Trial / NCT03094156

Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics

NCT03094156 ↗

Phase 1 Completed 39 enrolled Bial - Portela C S.A.
RandomizedSequentialDouble-blindTreatment

Summary

The purpose of the study was to To investigate 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 entacapone 200 mg.

Timeline

Start
2006-04-26
Primary completion
2006-07-11
Completion
2006-07-11

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 Entacapone Small molecule 200 mg Oral
Background benserazide Small molecule 50 mg Oral

Indications

Parkinson disease