NCT02071823

Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules

Single Dose Crossover Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules in Healthy Male Volunteers Following Administration of a 50 mg Dose / Fasted and Fed States

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study were to characterize the effects of food on the pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects.

Detailed description

Methodology: Single center, randomized, single dose, open-label, 2-period, 2-sequence, crossover study.

Conditions

• Parkinson

Interventions

Type	Name	Description
DRUG	BIA 9-1067	A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2014-02-26
• Last updated: 2015-01-09
• Results posted: 2015-01-09

Locations

1 site across 1 country: Canada