Bioequivalence Study of antiulcer drug Lansoprazole delayed release capsules 30mg in healthy adult male human subjects under fed condition

By Margret Chandira, B. S. Venkateswarlu, Dhananjay, Debjit, B. Jayakar


Abstract

Bioequivalence assessments necessary in abbreviated new drug application submissions to establish bioequivalence between a pharmaceutically equivalent generic drug product (T) and the corresponding reference listed drug (reference listed drug). Together with the determination of pharmaceutical equivalence, bioequivalence is a primary element in the determination of therapeutic equivalence. To assess bioavailability of Drug of ‘Test’ product comparing with ‘Reference’ product in normal, adult, human subjects under fasting or fed conditions. To monitor adverse events and ensure safety of the subjects. To further investigate the source of the observed variability in the Cmax of ‘Drug’. To evaluate the suitability of different study designs and statistical approaches for the assessment of bioequivalence between different (Test & Reference) ‘Drug’ tablet formulations. To monitor the safety and tolerability of a single dose of the test product as compared to the reference product in healthy human subjects. A randomized, single dose, open label, three treatment, three sequence, three period crossover bioequivalence study of Lansoprazole 30 mg Delayed Release Capsules of XXXX Limited ,India comparing with that of Prevacid® (containing Lansoprazole 30 mg Delayed Release Capsules ) in healthy, adult, male, human subjects under fed conditions.

 

Key Words : Lansoprazole, Bioequivalence study, Delayed Release capsules,adult male human subjects.

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