Effect of Food on BIA 5-1058

Status Completed

Clinical Trial 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.

Clinical Trial Description

Single-centre, open-label, randomised, single-dose, three-way crossover, three-part study in 54 healthy subjects. Duration of treatment: The study comprised a screening evaluation between 2 and 28 days before the first IMP (Investigational Medicinal Product) administration and 3 treatment periods of approximately 4 days, separated by wash-out periods of at least 7 days. A follow-up visit was performed approximately 7 days after discharge from the last period or early discontinuation. For each subject, the full duration of the participation in the study was approximately 9 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04991155
Study type	Interventional
Source	Bial - Portela C S.A.
Contact
Status	Completed
Phase	Phase 1
Start date	July 20, 2015
Completion date	September 22, 2015

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