MedTrace Logo

Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg

NCT03097211 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-03-31

No results posted yet for this study

Summary

The purpose of this study was to determine 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 nebicapone 150 mg.

Conditions

  • Parkinson Disease

Interventions

DRUG

Placebo

Placebo capsules. Orally, with 240 mL of potable water.

DRUG

BIA 6-512

The investigational products consisted of capsules containing BIA 6-512 25 mg, 50 mg, 75 mg, 100 mg. Orally, with 240 mL of potable water.

DRUG

Madopar® 250

Levodopa/benserazide immediate release tablets 200mg/50mg. Orally, with 240 mL of potable water.

DRUG

Nebicapone

Nebicapone 150 mg tablets. 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
2006-07-17
Primary Completion
2006-10-20
Completion
2006-10-20

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 NCT03097211 on ClinicalTrials.gov