Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Fluoxetine Tablets containing Fluoxetine 20 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Sarafem® 20 mg Tablets containing Fluoxetine 20 mg (Reference, Warner Chilcott LLC, USA) in Healthy Human Volunteers Under Fed Condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Cmax
Time frame: pre-dose to 72 hours post-dose
AUC
Time frame: pre-dose to 72 hours post-dose
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