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To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Aripiprazole 10 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.
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Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 21 days.
Aripiprazole plasma concentration was determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.
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Interventional model
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31 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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