NCT03090568

Bioavailability Study of BIA 5-453

Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions

• 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 purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.

Detailed description

This was a Single-centre, two-way crossover, randomised, open-label study in 12 healthy male volunteers. Subjects received a single oral 200 mg dose of BIA 5-453 following a standard meal in one period, and following at least 10 hours of fasting in another period. Treatment periods were separated by a washout interval of 2 weeks or more.

Conditions

• Hypertension
• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	BIA 5-453	BIA 5-453 capsules 50 mg. Route of administration: Oral. In one period subjects received 4 capsules of 50 mg of BIA 5-453 after a fasting of at least 10 hours, and in the other period subjects were dosed with 4 capsules of 50 mg of BIA 5-453 after a standard high-fat and high-calorie meal

Timeline

• Start date: 2008-07-15
• Primary completion: 2008-08-14
• Completion: 2008-08-14
• First posted: 2017-03-27
• Last updated: 2017-03-27

Locations

1 site across 1 country: France