Status:
COMPLETED
Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR
Lead Sponsor:
GlaxoSmithKline
Conditions:
Epilepsy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers
Eligibility Criteria
Inclusion
- Body weight \>50 kg (males) or \>45 kg (females) and BMI within the range 19 - 29.9 kg/m2 inclusive.
- Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, vital signs and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
Exclusion
- Female subjects of childbearing potential will not be eligible to participate who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria from at least the commencement of their last normal period prior to the first dose of study medication; and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 5 half lives of the study medication, whichever is the longest.
- Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at screening) or lactating.
- Female subjects using hormonal contraceptive precautions including progesterone-coated IUD
- Female subjects using hormonal replacement therapy.
- Subjects who received lamotrigine in a previous study (subjects who received placebo will be allowed).
- Current smokers of 10 or more cigarettes per day.
Key Trial Info
Start Date :
February 6 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2007
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00412191
Start Date
February 6 2007
End Date
April 27 2007
Last Update
August 7 2017
Active Locations (1)
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1
GSK Investigational Site
Berlin, Germany, 14050