Study of Lamotrigine 2×25 mg IR Tablets of Torrent Pharmaceuticals Limited, India and Lamictal® (Lamotrigine) 2×25 mg Tablets of GlaxoSmithKline, USA, in Healthy Human Adult Subjects, Under Fasting Conditions.
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A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Lamotrigine 2 x 25mg IR tablets of Torrent Pharmaceuticals Limited, India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of Glaxo-SmithKline, USA, in healthy human adult subjects, under fasting conditions.
Randomized, open label, two treatment, two period, two sequence, single dose, crossover, in 24+2 healthy human adult subjects to compare the single dose bioavailability of Torrent's Lamotrigine Tablets 2 × 25 mg and Lamictal® Tablets 2 × 25 mg of GlaxoSmithKline. Dosing periods were separated by a washout period of at least 21 days.
A Randomized, Open Label, Single Dose, Crossover, Bioequivalence Study of Lamotrigine 2×25 mg IR Tablets of Torrent Pharmaceuticals Limited., India and Lamictal® (Lamotrigine) 2×25 mg Tablets of GlaxoSmithKline, USA, in Healthy Human Adult Subjects, Under Fasting Conditions.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Healthy adult subjects of either sex between 18-55 years of age (inclusive), having a body mass index (BMI) between 18 and 27 kg/m2.
Subjects who have no evidence of underlying disease during screening and whose physical examination is performed within 21 days prior to commencement of the study.
Subjects whose screening laboratory values are within normal limits or values outside normal limits considered by the physician/Principal Investigator to be of no clinical significance.
Informed consent given in written form according to section 11.3 of the protocol.
of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
postmenopausal for at least 1 year.
surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).