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Pharmacokinetics, Safety and Tolerability of Concurrent Doses of BIA 5-1058 and Furosemide

NCT07173738 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-09-15

No results posted yet for this study

Summary

The purpose of this study is:

* To assess the effect of BIA 5 1058 400 mg on furosemide pharmacokinetics (PK).
* To assess the effect of furosemide 40 mg on the PK of BIA 5 1058.

Conditions

Interventions

DRUG

BIA 5-1058

During treatment period 1, a single oral dose of BIA 5-1058 (400 mg) will be administered on the morning of day 1, following an overnight fast of at least 10 h.

DRUG

Furosemide

During treatment period 2, a single oral dose of furosemide (40 mg) will be administered on the morning of day 1, following an overnight fast of at least 10 h.

DRUG

BIA 5-1058 and Furosemide

During treatment period 3, a single oral dose of both investigational medicinal product (IMPs) BIA 5-1058 (400 mg) concomitantly with furosemide (40 mg) will be administered on the morning of day 1, following an overnight fast of at least 10 h.

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Annelize Koch, Dr · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2018-09-07
Completion
2018-09-07

Countries

  • United Kingdom

Study Locations

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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 NCT07173738 on ClinicalTrials.gov