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Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics

NCT03091543 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-27

No results posted yet for this study

Summary

To investigate the effect of four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and 200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg and to assess the tolerability and safety of four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and 200 mg) when administered in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg.

Conditions

  • Parkinson Disease

Interventions

DRUG

Madopar® HBS 125

1 capsule of Madopar® HBS 125 (levodopa 100 mg / benserazide 25 mg) in an open label manner, concomitantly with BIA 6-512/Placebo.

DRUG

Placebo

2 capsules of placebo

DRUG

BIA 6-512 25 mg dose

1 capsule of 25 mg plus 1 capsule of placebo

DRUG

BIA 6-512 50 mg dose

2 capsules of 25 mg

DRUG

BIA 6-512 100 mg dose

1 capsule of 100 mg plus 1 capsule of placebo

DRUG

BIA 6-512 200 mg dose

2 capsules of 100 mg

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2004-05-04
Primary Completion
2004-07-23
Completion
2004-07-23

Countries

  • Portugal

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Entities

Drugs

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 NCT03091543 on ClinicalTrials.gov