NCT02779348

Effect of BIA 3-202 on the Pharmacokinetics and Pharmacodynamics of Warfarin

Effect of BIA 3-202 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (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 determine whether multiple-dose administration of nebicapone affects the pharmacokinetics of warfarin.

Detailed description

Study design and methodology: This was a single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers. The study consisted of 2 treatment periods separated by a washout period of 14 days or more. In one period, subjects received nebicapone 200 mg thrice-daily (tid) for 9 days, and a warfarin 25 mg single-dose concomitantly with the morning dose of nebicapone on Day 4. In the other period, a warfarin 25 mg single-dose was administered alone. Warfarin pharmacokinetic and pharmacodynamic profiles were characterised following warfarin dosing.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BIA 3-202	Nebicapone tablets 200 mg
DRUG	warfarin	Varfine® 5 mg (warfarin 5 mg) tablets

Timeline

• Start date: 2006-09-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2016-05-20
• Last updated: 2017-08-24

Locations

1 site across 1 country: Portugal