Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Magnesium DR Capsules 40 mg and Nexium® 40 mg DR Capsules of AstraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 4 days.
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Esomeprazole Magnesium DR Capsule containing Esomeprazole Magnesium 40 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Nexium® 40 mg DR Capsules containing Esomeprazole Magnesium 40 mg (Reference , AstraZeneca LP, USA) in Healthy Human Volunteers Under Fasting Condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
oral, cross over
oral, cross over
Cmax
Pharmacokinetic Evaluation
Time frame: pre-dose to 20 hours post-dose
AUC
Pharmacokinetic Evaluation
Time frame: pre-dose to 20 hours post-dose
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