NCT02172742

The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin

The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the effects of multiple-dose administration of BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.

Detailed description

Single centre, multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover study in 12 healthy volunteers. The study consisted of two 8-day treatment periods separated by a washout of 10 or more days. During each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 1200 mg once-daily (od) or matching placebo, concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093	BIA 2-093 1200 mg once-daily
DRUG	Placebo	matching placebo
DRUG	Digoxin	Digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

Timeline

• Start date: 2002-05-01
• Primary completion: 2002-07-01
• Completion: 2002-07-25
• First posted: 2014-06-24
• Last updated: 2025-04-06
• Results posted: 2014-12-31

Locations

1 site across 1 country: Portugal