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The objective of this study is to compare the relative bioavailability of fluoxetine HCL 40 mg capsules (by Ranbaxy Laboratories Limited) with that of PROZAC® 40 mg capsules (by Dista Products Company) following a single oral dose (1 x 40 mg capsule) in healthy, adult subjects under fasting conditions
This is a single-dose, open-label, randomized two-way crossover study to evaluate the bioequivalence of a test formulation, versus an equivalent dose of a commercially available reference drug product, in 36 adult subjects, under fasted conditions. Drug administrations are separated by at least 49 days.
Vital signs (sitting blood pressure and pulse rate) were obtained at baseline (Hour 0), and at post-dose Hours 3, 8, 12, 24, 48, 72, 360, and 1056.
Of the 36 subjects enrolled into the study, 31 subjects completed the study in its entirety. Five (5) subjects were dropped out from the study.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
fluoxetine HCL 40 mg capsules
Gateway medical research
Published on BioPortfolio: 2014-08-27T03:26:45-0400
The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg (1 x 40 ...
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