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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
oral, crossover
oral, crossover
Cmax
Pharmacokinetic Evaluation
Time frame: Pre-dose to 20 hour post dose
AUC
Pharmacokinetic Evaluation
Time frame: Pre-dose to 20 hour post dose
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