drugset / Trial / NCT03091543

Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics

NCT03091543

Phase 1 Completed 20 enrolled Bial - Portela C S.A.
RandomizedCrossoverSingle-blindTreatment

Summary

To investigate the effect of four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and 200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg and to assess the tolerability and safety of four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and 200 mg) when administered in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg.

Timeline

Start
2004-05-04
Primary completion
2004-07-23
Completion
2004-07-23

Drugs

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

Indications