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

  • STATUS
    Not Recruiting
  • participants needed
    24
  • sponsor
    Bial - Portela C S.A.
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Updated on 22 July 2024
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Accepts healthy volunteers

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

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.

Details
Condition Parkinson Disease
Age 18years - 45years
Treatment BIA 6-512 400 mg
Clinical Study IdentifierNCT03095092
SponsorBial - Portela C S.A.
Last Modified on22 July 2024

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