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Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Benserazide

NCT02778594 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-06-14

No results posted yet for this study

Summary

The purpose of this study is to determine the effect of three single oral doses of nebicapone (50 mg, 100 mg and 200 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled release levodopa 100 mg/benserazide 25 mg (Madopar® HBS 125).

Conditions

  • Parkinson's Disease (PD)

Interventions

DRUG

BIA 3-202

nebicapone 50 mg tablets; oral use

DRUG

Placebo

Nebicapone matching placebo tablets

DRUG

levodopa 100 mg / benserazide 25 mg

Madopar® HBS 125 (levodopa 100 mg / benserazide 25 mg) capsules; oral use

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
2005-09-30
Primary Completion
2005-11-30
Completion
2005-11-30

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 NCT02778594 on ClinicalTrials.gov