NCT01526083

Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males

Single-center, Open-label, Randomized 2-way Crossover Study of the Effect of Lacosamide 200 mg Twice Daily on the Single-dose Pharmacokinetics and Pharmacodynamics of Warfarin (25 mg) in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid) on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy male volunteers.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
OTHER	Lacosamide	Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days
OTHER	Warfarin	Strength: 5 mg, Form: Tablet, Frequency: 1 single dose in each period In total, during the two periods, each healthy volunteer will receive 2 single doses 3 weeks apart. Duration: single dose

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-02-03
• Last updated: 2012-05-07

Locations

1 site across 1 country: Netherlands