Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
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...
Brief Summary
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”
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
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Lamotrigine
Outcome Measures for this Clinical Trial
Primary Measures
- 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
- Time Frame: 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
- Time Frame: 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 Measures
- 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.
- Time Frame: Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above
- Time Frame: Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 19 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: GlaxoSmithKline Industry
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MRCP, FFPM Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00449774
Study ID Number: LBI108617
ClinicalTrials.gov Identifier: NCT00449774
Health Authority: United States: Food and Drug Administration
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00449774
