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Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC)

NCT04265027 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-02-11

No results posted yet for this study

Summary

This study evaluates the bioavailability and bioequivalence between two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage strengths (50 mg and 25 mg) after single and multiple dose administration under fasting conditions in healthy volunteers and assess soluble catechol O methyltransferase (S-COMT) activity in 2 API sources of OPC at two different dosage strengths (50 mg and 25 mg) after single and multiple dose administration under fasting conditions in healthy volunteers

Conditions

  • Parkinson Disease

Interventions

DRUG

50 mg BIA 9 1067

Hard Capsule; Oral

DRUG

25 mg BIA9 1067

Hard Capsule; Oral

DRUG

50 mg Ongentys

Hard Capsule; Oral

DRUG

25 mg Ongentys

Hard Capsule; Oral

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-02-20
Primary Completion
2018-07-24
Completion
2018-07-24

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 NCT04265027 on ClinicalTrials.gov