Effect of BIA 5-1058 400 mg on Warfarin Pharmacokinetics

Status Completed

Clinical Trial Summary

The purpose of this study is: - To investigate CYP2C9 inhibition by BIA 5-1058 through the assessment of its effect on the Pharmacokinetic (PK) of S-warfarin, a substrate of CYP2C9. - To assess the effect of warfarin 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 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 2 weeks (including the screening period). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04994119
Study type	Interventional
Source	Bial - Portela C S.A.
Contact
Status	Completed
Phase	Phase 1
Start date	February 23, 2018
Completion date	May 23, 2018

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