NCT03090724

Pharmacokinetics of BIA 5-453 and Its Metabolites

Single-dose and Steady-state Pharmacokinetics of BIA 5-453 and Its Metabolites in Healthy Male Elderly Subjects Compared With Those in Healthy Male Young Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to assess the effects of age on the pharmacokinetic (PK) profile of BIA 5-453 and its metabolites.

Detailed description

Single-centre, open-label, parallel group, non-randomised study in 12 healthy elderly and 12 healthy younger male subjects, who participated in 2 consecutive phases: Phase A: a single-dose phase (including a wash out period); Phase B: a multiple-dose phase during 7 days (steady state).

Conditions

• Hypertension
• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	BIA 5-453	100 mg of BIA 5-453 (combination of two 50 mg capsules); Oral, once-daily (QD), in the morning in fasting conditions

Timeline

• Start date: 2008-06-13
• Primary completion: 2008-08-12
• Completion: 2008-08-12
• First posted: 2017-03-27
• Last updated: 2017-03-27

Locations

1 site across 1 country: France