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Clinical Trial Summary

The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg.


Clinical Trial Description

A single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 18 healthy subjects each. This study consisted of a once-daily administration of BIA 9 1067 (5 mg, 15 mg or 50 mg) or placebo for 18 days. Twelve (12) hours after the BIA 9 1067 dose, a single-dose of levodopa/carbidopa 100/25 mg was administered on Day 11 and a single-dose of levodopa/benserazide 100/25 mg was administered on Day 18. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02169414
Study type Interventional
Source Bial - Portela C S.A.
Contact
Status Completed
Phase Phase 1
Start date February 2010
Completion date July 2010

See also
  Status Clinical Trial Phase
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Completed NCT02169895 - Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide Phase 1
Completed NCT02169479 - Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa Phase 1
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