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Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg)

NCT02763852 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-05-05

No results posted yet for this study

Summary

The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA 3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4 different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of standard levodopa 100 mg/benserazide 25 mg (Madopar® 125) in adult male and female healthy volunteers.

Conditions

Interventions

DRUG

BIA 3-202

The study consisted of 5 treatment periods. Eligible subjects were admitted to the UFH on the morning of the day prior to receive the trial medication (dosing day) and remained in the unit for at least 30 h post-dose. Subjects were to receive BIA 3-202 50 mg, 100 mg, 200 mg, 400 mg and placebo at 5 separate treatment periods.

DRUG

Placebo

Placebo dose consisted of 5 tablets matching BIA 3-202 100 mg tablets; oral route.

DRUG

Madopar® 125

Levodopa 100 mg/benserazide 25 mg capsules (Madopar® 125, marketed by Roche products Limited); oral route.

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2001-07-31
Completion
2001-07-31

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 NCT02763852 on ClinicalTrials.gov