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

NCT03095092 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-03-29

No results posted yet for this study

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

Conditions

  • Parkinson Disease

Interventions

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.

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-23
Primary Completion
2005-07-07
Completion
2005-07-07

Countries

  • Portugal

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095092 on ClinicalTrials.gov