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Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics

NCT03091868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-03-27

No results posted yet for this study

Summary

To investigate the effect of rising oral single-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 immediate release levodopa/carbidopa 100/25 mg (Sinemet® 100/25) or with a single-dose of Sinemet® 100/25 plus a single-dose of entacapone (Comtan®) 200 mg and to assess the tolerability and safety of rising single oral doses of BIA 6-512 when administered in combination with a single-dose of Sinemet® 100/25 or with a single-dose of Sinemet® 100/25 plus a single-dose of Comtan® 200 mg.

Conditions

  • Parkinson Disease

Interventions

DRUG

Placebo oral capsule

Matching placebo capsules. Oral administration.

DRUG

Sinemet® 100/25

Single-dose of immediate release levodopa/carbidopa 100/25 mg consisted of 1 tablet of Sinemet® 100/25. Route of administration: Oral.

DRUG

Comtan®

Single-dose of entacapone 200 mg consisted of 1 tablet of Comtan®. Route of administration: Oral.

DRUG

BIA 6-512 25 mg

BIA 6-512 capsules strengths 25 mg. Oral administration.

DRUG

BIA 6-512 100 mg

BIA 6-512 capsules strengths 100 mg. Oral administration.

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
2004-11-03
Primary Completion
2005-02-28
Completion
2005-02-28

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 NCT03091868 on ClinicalTrials.gov