NCT01533077

Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa

Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To investigate the pharmacokinetics of levodopa when administered concomitantly with BIA 9-1067 or 1 hour after.

Detailed description

Single-centre, open-label, randomized, gender-balanced, crossover study with four consecutive single-dose treatment periods.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	BIA 9-1067	50 mg of BIA 9-1067 (single-dose)
DRUG	Sinemet® 100/25 mg	immediate-release levodopa/carbidopa 100/25 (single-dose).

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-10-01
• Completion: 2010-02-01
• First posted: 2012-02-15
• Last updated: 2015-12-22
• Results posted: 2015-12-22

Locations

1 site across 1 country: Canada