Status:
COMPLETED
Comparison of Brivaracetam Oral Tablet (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam Injection (100 mg) in Healthy Volunteers
Lead Sponsor:
UCB Pharma SA
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.
Eligibility Criteria
Inclusion
- Subject is a healthy male or female volunteer aged 18-55 years inclusive
- Subject has a Body Mass Index (BMI) of 18.0 - 30.0 kg/m\^2 and a weight of at least 50 kg (males) or 45 kg (females)
- Subject has normal vital signs values, Electrocardiograms (ECGs) and clinical laboratory values
- Female subjects should have a negative pregnancy test or be of non-childbearing potential
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)
- Subject has an intolerance or allergy against the compound or related drugs
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01796899
Start Date
January 1 2013
End Date
March 1 2013
Last Update
April 15 2013
Active Locations (1)
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1
1
Zuidlaren, Netherlands