Study to Compare Two Formulations of Lamotrigine in Healthy Subjects
- Registration Number
- NCT00410371
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
- Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 to 30 kg/m2 inclusive.
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GI267119 GI267119 25 mg ODT tablet strength GI267119 Lamotrigine 25 mg ODT tablet strength
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points throughout study
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of lamotrigine in treating mental disorders and how do they relate to NCT00410371?
How do the pharmacokinetic profiles of the two ODT formulations in NCT00410371 compare to IR lamotrigine in healthy subjects?
What biomarkers are associated with lamotrigine response in mental disorders and could they inform patient selection for ODT formulations?
What adverse events are commonly reported with lamotrigine ODTs versus IR formulations in phase 1 trials like NCT00410371?
How do taste-masking approaches in lamotrigine ODTs affect drug absorption and tolerability in phase 1 studies?
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Lincoln, Nebraska, United States
GSK Investigational Site🇺🇸Lincoln, Nebraska, United States