Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Delayed Release Capsule 1 × 40 mg and Nexium 1× 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 7 days.
An Open Label, Randomized, 2 -Period, 2-Treatment, 2 Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Delayed Release Capsule 40 mg \[Test Formulation, Torrent Pharmaceutical Ltd., India\]Versus Nexium 40 mg Delayed Release Capsule containing Esomeprazole 40 mg. \[Reference Formulation, AastraZeneca LP, USA\] in Healthy Human Volunteers Under Fed Conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
oral, cross over
oral, cross over
Cmax
Pharmacokinetic Evaluation
Time frame: Pre dose to 24 hour post dose
AUC
Pharmacokinetic Evaluation
Time frame: Pre dose to 24 hour post dose
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