NCT02287415

The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin

The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin 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

Multiple-dose, open-label, single-period study consisting of three consecutive phases

Detailed description

Multiple-dose, open-label, single-period study consisting of three consecutive phases: Phase A - run-in warfarin dose-finding phase Phase B - warfarin pharmacokinetics (PK) and international normalised ratio (INR) profiling Phase C - warfarin alone at their individualised doses

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093
DRUG	Warfarin

Timeline

• Start date: 2002-05-01
• Primary completion: 2002-07-01
• Completion: 2002-07-01
• First posted: 2014-11-10
• Last updated: 2014-12-01
• Results posted: 2014-12-01