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Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan

NCT04991207 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-08-05

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 the PK of bosentan.
* To assess the effect of bosentan on the PK of BIA 5 1058

Conditions

Interventions

DRUG

BIA 5-1058

Oral BIA 5-1058 (Zamicastat) 100 mg tablets

DRUG

bosentan

Oral Tracleer (bosentan) 125 mg film coated tablets

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2018-05-14
Completion
2018-05-14

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT04991207 on ClinicalTrials.gov