MedTrace Logo

Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics

NCT03094156 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-03-30

No results posted yet for this study

Summary

The purpose of the study was to To investigate whether the administration of BIA 6-512 (25 mg, 50 mg, 75 mg and 100 mg) at steady-state affects the pharmacokinetics of levodopa when administered in combination with a single-dose of immediate release levodopa/benserazide 200/50 mg or with a single-dose of immediate release levodopa/benserazide 200/50 mg plus a single-dose of entacapone 200 mg.

Conditions

  • Parkinson Disease

Interventions

DRUG

Placebo

1 capsule of placebo \[to be taken orally, with 240 mL of potable water\]

DRUG

BIA 6-512

1 capsule of BIA 6-512 25mg or 1 capsule of BIA 6-512 50 mg or 1 capsule of BIA 6-512 75 mg or 1 capsule of BIA 6-512 100 mg \[to be taken orally, with 240 mL of potable water\]

DRUG

Madopar® 250

Levodopa/benserazide immediate release tablets 200mg/50mg \[to be taken orally, with 240 mL of potable water\]

DRUG

Comtan®

Entacapone 200 mg tablets \[to be taken orally, with 240 mL of potable water\]

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2006-04-26
Primary Completion
2006-07-11
Completion
2006-07-11

Countries

  • Portugal

More Related Trials

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 NCT03094156 on ClinicalTrials.gov