To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets (Wyeth Laboratories, USA) in 42 (+ 4 standby) healthy, adult, human subjects under fasting conditions.
This is a Open label, balanced, randomized two-treatment, two-period,two-sequence, crossover bioequivalence study with at least 07 days washout period between each drug administration under fasting conditions.42 (+4 standby) healthy, adult, human subjects were enrolled. A single oral dose of40 mg of pantoprazole delayed release tablet will be administered along with 240 mL of drinking water after an overnight fast of at least 10 hours in each period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Pantoprazole Sodium DR Tablets 40 mg
VimtaLabsLtd.
Hyderabad, Andhrapradesh, India
Bioequivalence on Cmax and AUC parameters
Time frame: 2 months
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