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Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics

NCT02169414 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2015-12-24

Study results available
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Summary

The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg.

Conditions

  • Parkinson's Disease (PD)

Interventions

DRUG

BIA 9-1067 5 mg

OPC, Opicapone

DRUG

BIA 9-1067 25 mg

OPC, Opicapone

DRUG

levodopa/carbidopa 100/25

immediate (standard) release levodopa/carbidopa 100/25

DRUG

Placebo

PLC, Placebo

DRUG

levodopa/benserazide 100/25 mg

immediate (standard) release levodopa/benserazide

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
2010-02-28
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • France

Study Locations

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 NCT02169414 on ClinicalTrials.gov