NCT03095092

Effect of Food on BIA 6-512 (Trans-resveratrol)

The Effect of Food on the Pharmacokinetics of a Single 400 mg Oral Dose of BIA 6-512 (Trans-resveratrol) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study was to investigate the effect of food on the pharmacokinetics of a single 400 mg dose of BIA 6-512 (trans-resveratrol) in healthy volunteers

Detailed description

Single-centre, open-label, randomised, two-way crossover study in 24 healthy male and female subjects. The study consisted of 2 single-dose periods separated by a washout of 7 days or more. Eligible subjects were admitted to the UFH on the day (Day 0) prior to receiving the dose of study medication (Day 1). On the morning of the next day (Day 1), a BIA 6-512 400 mg dose was administered following either a standard breakfast (Test) or at least 8 hours of fasting (Reference). Subjects remained confined in the UFH from admission (Day 0) until at least 24 h post dose (Day 2); then, they were discharged and returned for the second treatment period or a follow-up visit.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	BIA 6-512 400 mg	4 capsules of BIA 6-512 100 mg / oral administration with 240 mL of potable water .Subjects were administered a 400 mg BIA 6-512 single-dose on two different occasions. In one treatment period subjects were dosed with a single oral dose of 400 mg after a fasting of at least 8 hours, and in the other treatment period subjects were dosed with a single oral dose of 400 mg after a standard meal. Subjects were requested to fast overnight for at least 8 hours before product administration.

Timeline

• Start date: 2005-05-23
• Primary completion: 2005-07-07
• Completion: 2005-07-07
• First posted: 2017-03-29
• Last updated: 2017-03-29

Locations

1 site across 1 country: Portugal