Objective: to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA. Dosing periods were separated by a washout period of 8 days. Study Design: randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects
Study Type
INTERVENTIONAL
Trident Life sciences Limited
Hyderabad, Andhra Pradesh, India
Trident Life Sciences Limited
Hydrabad, Andhra Pradesh, India
bioequivalence based on Composite of Pharmacokinetics
bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.
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