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BIOEQUIVALENCE STUDY OF FIXED DOSE COMBINATION (FDC) OF METFORMIN HCl (ER) AND GLIMEPIRIDE (IR) TABLETS. Hitesh Verma, Bindia Gupta

BIOEQUIVALENCE STUDY OF FIXED DOSE COMBINATION (FDC) OF METFORMIN HCl (ER) AND GLIMEPIRIDE (IR) TABLETS.

Hitesh Verma, Bindia Gupta

International Journal of Pharmacology & Toxicology Science 2013; 3(6): 12-18

Abstract

Present study aimed to determine bioequivalence of tablets containing a fixed-dose combination (FDC) of Metformin HCl 500mg (ER) and Glimepiride 2mg (IR) from two different companies. A balanced, randomized, single dose, two treatment, two period, two sequence, open label, crossover study was carried out in healthy Indian male volunteers with a wash out period of atleast 5 days between two consecutive treatments. After overnight fasting, subjects were randomly assigned to receive one tablet of either test or reference product with 240 mL of drinking water. Blood samples of each subject were collected before dosing and after dosing at specified time intervals. Various pharmacokinetic parameters viz. Cmax, Tmax, AUC0-t, AUC0-inf were determined for both test and reference products. The percentage ratios of least square means of test product and reference product were found to be comparable for Cmax, AUC0-t and AUC0-inf. Hence, it can be concluded that the formulation manufactured by Overseas Health Care Pvt. Ltd. (GLUCUT-2MT) is bioequivalent to reference product manufactured by Dr. Reddy’s Ltd. (GLIMY-M2).


Keywords Bioequivalence study, Glimepiride, Indian volunteers, Metformin, Type II diabetes
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