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About
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
Full description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Lamotrigine Extended Release tablets 200mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL XR(containing Lamotrigine) Extended Release tablets 200mg of GlaxoSmithKline Research Triangle Park, NC in healthy, adult, human subjects under fed conditions.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Subjects were selected based on the following inclusion criteria:
Provide written informed consent.
Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg.
Having a body mass index between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m 2.
Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance).
Female Subjects
Exclusion Criteria The subjects were excluded based on the following criteria during screening and during the study:
Primary purpose
Allocation
Interventional model
Masking
32 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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