Comparative bioavailability study of three oral preparations of gliclazide tablets

Lee, Kok Kitt (2006) Comparative bioavailability study of three oral preparations of gliclazide tablets. Universiti Malaysia Sabah. (Unpublished)

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Abstract

The bioavailability of a generic preparation of glic1azide (Glimicron® 80 mg) was compared with the innovator products, Diamicron® 80 mg and a modified release tablet, Diamicron® MR 30 mg. Six healthy adult male volunteers participated in the study conducted according to a randomized, three-way crossover design and the plasma concentrations obtained were analyzed according to a validated liquid chromatography-tandem mass spectrometry method. The bioavailability was compared using the parameters total area under the plasma level-time curve (AUC₀-∞), peak plasma concentration (Cmax), and time to reach peak plasma concentration (tmax). No statistically significant difference was observed between the AUC₀-∞ value of Glimicron® 80 mg and normalized AUC₀-∞ value for Diamicron® MR 30 mg. However, there was a statistically significant difference in the Cmax and tmax values for all the three pairs of the three preparation combinations. Meanwhile, after normalizing for dose difference, the 90% confidence intervals of the AUC₀-∞ and Cmax values of Glimicron® 80 mg over those of Diamicron® MR 30 mg were found to lie between 0.8-1.3 and 1.7-2.7 respectively. Similar to that observed with Glimicron® 80 mg, the Diamicron® MR 30 mg preparation also has a markedly higher extent of bioavailability over the conventional Diamicron ® 80 mg preparation, being between 4.9 and 8.0 times higher. There was no statistically significant difference among the elimination rate constant (ke) values of the three preparations and were similar to those reported in the literature. Based on these statistical inferences, it can be concluded that the extent of bioavailability of Glimicron® 80 mg was comparable to that of Diamicron® MR 30 mg with Diamicron® MR 30 mg exhibiting a sustained rate of absorption.

Item Type: Academic Exercise
Uncontrolled Keywords: bioavailability, glic1azide, Diamicron, Glimicron, level-time curve, preparation combination, mass spectrometry method
Subjects: T Technology > TP Chemical technology
Divisions: SCHOOL > School of Science and Technology
Depositing User: MDM SITI AZIZAH IDRIS
Date Deposited: 29 Apr 2014 04:51
Last Modified: 13 Oct 2017 03:43
URI: http://eprints.ums.edu.my/id/eprint/8902

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