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Effect of Food on BIA 5-1058

NCT04991155 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-08-05

No results posted yet for this study

Summary

The aim of this study is to investigate the effect of food on the pharmacokinetic (PK) profile of BIA 5-1058 after a single dose in healthy subjects.

Conditions

Interventions

DRUG

BIA 5-1058

BIA 5-1058 (tablets 100 mg) was administered orally with 240 mL (Part 1) or 270 mL (Part 2 and Part 3) of water, in one period in the morning under fasting conditions (after at least a 10-hour overnight fast), in one period in the morning after a moderate meal, and in the other period at lunch after a moderate meal.

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
2015-07-20
Primary Completion
2015-09-22
Completion
2015-09-22

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Entities

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 NCT04991155 on ClinicalTrials.gov