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Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Mg DR Capsule 1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 5 days.
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An open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Mg DR Capsule containing Esomeprazole Mg 40 mg [ Test Formulation, Torrent Pharmaceutical Ltd., India] Versus Nexium 40 mg DR Capsule containing Esomeprazole 40 mg [Reference Formulation, AastraZeneca LP, USA] Under administered as the contents of capsule sprinkled over apple sauce in Healthy Human Volunteers Under Fasting Condition.
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56 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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