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Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic

NCT01519284 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2015-08-20

Study results available
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Summary

To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.

Conditions

  • Parkinson Disease

Interventions

DRUG

BIA 9-1067 5 mg

BIA 9-1067 OPC, Opicapone 5 mg

DRUG

Entacapone

Entacapone 200 mg

DRUG

Placebo

placebo (four times a day)

DRUG

levodopa/carbidopa

standard release levodopa/carbidopa 100/25 mg (single-dose)

DRUG

BIA 9-1067 15 mg

BIA 9-1067 OPC, Opicapone 15 mg

DRUG

BIA 9-1067 30 mg

BIA 9-1067 OPC, Opicapone 30 mg

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Manuel Vaz-da-Silva, MD, PhD · BIAL - Portela & Cª S.A

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
2009-11-30
Primary Completion
2010-02-28
Completion
2011-06-30

Countries

  • Portugal

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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 NCT01519284 on ClinicalTrials.gov