PRODUCT LITERATURE

Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers

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Glimepiride/metformin (2/500 mg) is an oral antihyperglycemic agent for the treatment of type 2 diabetes. A generic glimepiride/metformin (2/500 mg) fixed-dose combination (FDC) tablet was developed recently. This study was designed to collect data for submission to Korean regulatory authorities to allow the marketing of the test formulation. We evaluated the comparative
bioavailability and tolerability of the test and reference formulations in healthy male adult volunteers.This single-dose, randomized, double-blind, two-way crossover trial was conducted at Bestian Medical Center in Bucheon, Korea. In total, 40 male Korean volunteers were enrolled. The subjects were randomized to receive an FDC tablet containing the glimepiride/metformin (2/500 mg) test or reference formulation, and pharmacokinetic(PK) parameters were measured

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: .,

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Language

English

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NONE

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Subject(s)

Gluvas M
Glimepiride
Metformin

Specific Detail Info

Iranian Journal of Pharmaceutical Research (2014), 13 (2): 365-371

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