Status:
COMPLETED
Study to Compare Two Formulations of Lamotrigine in Healthy Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Mental Disorders
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
This study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
Eligibility Criteria
Inclusion
- Body weight \>50 kg (males) or \>45 kg (females) and BMI within the range 19 to 30 kg/m2 inclusive.
Exclusion
- Female subjects of childbearing potential will not be eligible to participate 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 (positive serum human chorionic gonadotrophin (hCG) test at Screening and pre-dose to the study) 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
- Current smokers of 10 or more cigarettes per day
Key Trial Info
Start Date :
December 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2007
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00410371
Start Date
December 28 2006
End Date
January 25 2007
Last Update
September 12 2017
Active Locations (1)
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1
GSK Investigational Site
Lincoln, Nebraska, United States, 68502