NCT02305316

Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone

Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.

Detailed description

Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more. A total of twenty-eight (28) healthy volunteers received a single dose of 50 mg OPC, orally.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	BIA 9-1067 non-micronized
DRUG	BIA 9-1067 micronized

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-12-02
• Last updated: 2015-08-21
• Results posted: 2015-08-21