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Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone

NCT02305316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-08-21

Study results available
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Summary

Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.

Conditions

  • Parkinson Disease

Interventions

DRUG

BIA 9-1067 non-micronized

DRUG

BIA 9-1067 micronized

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-03-31
Completion
2014-03-31

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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 NCT02305316 on ClinicalTrials.gov