Status:
COMPLETED
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Mental Disorders
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and...
Eligibility Criteria
Inclusion
- Healthy male or female subjects aged 19 to 55 years inclusive
- BMI within the range 19 to 32 kg/m2 inclusive.
Exclusion
- Female subjects of childbearing potential will not be eligible if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.
- Female subject is pregnant or lactating.
- Female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (IUD).
- Female subjects using hormonal replacement therapy.
- History of regular alcohol consumption \> 7 drinks week for women and 14 drinks week for men
- Current smokers of 10 or more cigarettes per day
Key Trial Info
Start Date :
May 7 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2007
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00449774
Start Date
May 7 2007
End Date
June 19 2007
Last Update
August 8 2017
Active Locations (1)
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1
GSK Investigational Site
Dallas, Texas, United States, 75247