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A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067

NCT01568034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-01-12

Study results available
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Summary

The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients.

Conditions

Interventions

DRUG

BIA 9-1067

BIA 9-1067 - 25 mg single-dose

DRUG

BIA 9-1067

BIA 9-1067 - 50 mg single-dose

DRUG

BIA 9-1067

BIA 9-1067 - 100 mg single-dose

DRUG

Placebo

single-dose

DRUG

Levodopa/Carbidopa

Levodopa 100 mg Carbidopa 25 mg

DRUG

Levodopa/Benzerazide

Levodopa 100 mg Benzerazide 25 mg

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Joaquim Ferreira, MD, PhD · Hospital de Santa Maria, Lisbon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Portugal
  • Romania
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01568034 on ClinicalTrials.gov