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

Pulmonary Arterial Hypertension Clinical Trial

Official title:
An Open-Label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Sildenafil in Healthy Subjects Under Fasting Conditions

Clinical Trial Summary

The purpose of this study is: - To assess the effect of BIA 5 1058 400 mg on the pharmacokinetics (PK) of sildenafil. - To assess the effect of sildenafil on the PK of BIA 5-1058.

Clinical Trial Description

This study was an open label, three period, fixed sequence study in healthy male and female subjects performed under fasting conditions at a single study center. The study comprised: - Screening during Days -28 to -2 (both inclusive). - Three treatment periods separated by a washout period of at least 10 days. Duration of Treatment: The duration of participation for each subject was approximately 2 months and 3 weeks (including the screening period). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04994860
Study type Interventional
Source Bial - Portela C S.A.
Contact
Status Completed
Phase Phase 1
Start date March 22, 2018
Completion date June 7, 2018
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