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Relative Bioavailability and Bioequivalence of Opicapone

NCT03820037 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-12-31

No results posted yet for this study

Summary

the purpose assess the relative bioavailability and bioequivalence of two active pharmaceutical ingredient (API) sources of opicapone (OPC, Ongentys® and BIA 9-1067) following single 50 mg dose administration under fasting conditions in healthy volunteers

Conditions

  • Parkinson Disease

Interventions

DRUG

Ongentys

single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions

DRUG

BIA 9-1067 (test)

single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions

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
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2019-06-09
Completion
2019-06-09

Countries

  • United Kingdom

Study Locations

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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 NCT03820037 on ClinicalTrials.gov