Study to Compare Two Formulations of Lamotrigine in Healthy Subjects
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, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
This study intends to compare the pharmacokinetic characteristics, 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 Compare the Pharmacokinetic Characteristics, Safety and Tolerability of Two Formulations of Lamotrigine in Healthy Subjects
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Lamotrigine AUC(0-O) 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: tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate
Time points: throughout study
Eligibility
Minimum age: 19 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
GSK Clinical Trials Call Center, Lincoln, Nebraska 68502, United States
Additional Information
Starting date: January 2007
Last updated: February 14, 2007
|
