Parkinson Disease Clinical Trial
Official title:
The Effect of Food on the Pharmacokinetics of a Single 400 mg Oral Dose of BIA 6-512 (Trans-resveratrol) in Healthy Subjects
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
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.
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