Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Lamotrigine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MRCP, FFPM, Study Director, Affiliation: GlaxoSmithKline
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 female volunteers
Clinical Details
Official title: An Open-Label, Randomised, Single-Dose, Parallel-Group Study to Demonstrate Bioequivalence of Two Formulations and the Effect of Food and Water on One Formulation of Lamotrigine in Healthy Male and Female Volunteers
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Bio-equivalence Study
Primary outcome: Lamotrigine AUC(0-inf) and Cmax. Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours
Secondary outcome: Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above. Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate at various times during the study.
Eligibility
Minimum age: 19 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male or female subjects aged 19 to 55 years inclusive
- BMI within the range 19 to 32 kg/m2 inclusive.
Exclusion Criteria:
- 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
Locations and Contacts
GSK Clinical Trials Call Center, Dallas, Texas 75247, United States
GSK Clinical Trials Call Center, Austin, Texas 78752, United States
Additional Information
Starting date: May 2007
Last updated: September 24, 2007
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