Status:
COMPLETED
Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males
Lead Sponsor:
UCB Pharma
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief 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 volunte...
Eligibility Criteria
Inclusion
- Healthy male volunteers 18-55 years of age
- BMI 18.0-30.0 kg/m2 and weight at least 50 kg
- Tympanic body temperature 35.0-37.5°C (95 and 99.5°F) inclusive
Exclusion
- Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months
- Volunteer is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
- Volunteer is taking Warfarin or Non Steroidal Anti-Inflammatory Drug (NSAID)
- Volunteer has history of suicide attempt
- Volunteer has history of coagulation abnormalities, occult blood in stool, gastrointestinal ulcer, surgery within 6 months
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01526083
Start Date
January 1 2012
End Date
March 1 2012
Last Update
May 7 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
001
Zuidlaren, Netherlands