Pharmacokinetic comparison of a new glimepiride 1-mg + metformin 500-mg combination tablet formulation and a glimepiride 2-mg + metformin 500-mg combination tablet formulation: a single-dose, randomized, open-label, two-period, two-way crossover study in healthy, fasting Korean male volunteers

Clinical Therapeutics
Bo-Hyung KimKyung-Sang Yu

Abstract

Coadministration of glimepiride and metformin has been used to achieve glucose control. Because compliance with a multiple medication regimen can be difficult for some patients, combination tablets of glimepiride + metformin might be a suitable alternative for these patients. This study was conducted to compare the pharmacokinetics of test and reference formulations of glimepiride + metformin fixed-dose combination tablets under fasting conditions to meet the regulatory requirements for marketing approval of a new drug in Korea. This was a single-dose, randomized, open-label, 2-period, 2-way crossover study conducted between March 2007 and May 2007. Healthy fasting Korean men were randomized to 1 of 2 dosing sequences: a single oral administration of a fixed-dose glimepiride 1-mg + metformin 500-mg combination tablet (test) followed by single oral administration of a fixed-dose glimepiride 2 mg + metformin 500 mg combination tablet (reference), separated by a 1-week washout period between doses; or a single oral administration of a fixed-dose glimepiride 2-mg + metformin 500-mg combination tablet followed by single oral administration of a fixed-dose glimepiride 1 mg + metformin 500-mg combination tablet, separated by a 1-week ...Continue Reading

References

Oct 27, 2001·Diabetic Medicine : a Journal of the British Diabetic Association·G CharpentierS Halimi
Jan 27, 2004·The Annals of Pharmacotherapy·Umesh A ShuklaKarl-Heinz Lehr
Jan 26, 2006·Diabetic Medicine : a Journal of the British Diabetic Association·L A DonnellyE R Pearson
Aug 5, 2008·Therapeutische Umschau. Revue thérapeutique·Andrej Zeyfang

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Citations

Jul 1, 2013·Clinical Pharmacology in Drug Development·Sally A HelmyNoha O Mansour

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