drugset / Trial / NCT03091868

Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics

NCT03091868

Phase 1 Completed 80 enrolled Bial - Portela C S.A.
RandomizedSequentialDouble-blindTreatment

Summary

To investigate the effect of rising oral single-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 immediate release levodopa/carbidopa 100/25 mg (Sinemet® 100/25) or with a single-dose of Sinemet® 100/25 plus a single-dose of entacapone (Comtan®) 200 mg and to assess the tolerability and safety of rising single oral doses of BIA 6-512 when administered in combination with a single-dose of Sinemet® 100/25 or with a single-dose of Sinemet® 100/25 plus a single-dose of Comtan® 200 mg.

Timeline

Start
2004-11-03
Primary completion
2005-02-28
Completion
2005-02-28

Drugs

EvaluationDrugModalityDoseRoute
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 Entacapone Small molecule 200 mg Oral
Background levodopa/carbidopa Unknown 25 mg Oral
Background levodopa/carbidopa Unknown 100 mg Oral

Indications