Status and phase
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About
This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female subjects aged from 19 to 55 years, inclusive.
Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 - 32 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
Female subjects of non-child bearing potential will be eligible to participate if they meet the following criteria:
A negative pre-study Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, and HIV antibody result at screening.
A negative pre-study urine drug screen.
A negative screen for alcohol (urine, blood or breath test).
Signed and dated written informed consent prior to admission to the study.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
209 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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