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Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202

NCT02772627 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-05-13

No results posted yet for this study

Summary

The purpose of this study is to investigate the tolerability and safety of three multiple dose regimens of nebicapone (BIA 3-202 100 mg, 200 mg, and 300 mg 6 times daily) in healthy volunteers. To characterise the steady-state pharmacokinetic and erythrocyte COMT inhibition profiles of nebicapone in healthy volunteers.

Conditions

Interventions

DRUG

Nebicapone

Nebicapone 100 mg tablets; oral route.

DRUG

Placebo

Placebo tablets; oral route.

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2001-12-31
Completion
2001-12-31

Countries

  • Portugal

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Entities

Drugs
Diseases

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 NCT02772627 on ClinicalTrials.gov