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Pharmacology: Gliclazide is a hypoglycaemic sulphonylurea, oral antidiabetic, active substance differing from other related compunds by an N-containing heterocyclic ring with an endocyclic bond. Gliclazide reduces blood glucose levels by stimulating insulin secretion from the B-cells of the islets of Langerhans. Increase in postprandial insulin and C-peptide secretion persists after two years of treatment.
In addition to these metabolic properties, gliclazide has haemo-vascular properties.
Effects on insulin release: In type 2 diabetics, gliclazide restores the first peak of insulin secretion in response to glucose and increases the second phase of insulin secretion. A significant increase in insulin response is seen in response to stimulation induced by a meal or glucose absorption.
Haemovascular properties: Gliclazide decreases microthrombosis process by two mechanisms which may be involved in complications of diabetes: A partial inhibition of platelet aggregation and adhesion, with a decrease in the markers of platelet activation (beta thromboglobulin, thromboxane B2).
An action on the vascular endothelium fibrinolytic activity with an increase in tPA activity.
Pharmacokinetics: The Pharmacokinetics parameters: Twenty four subjects (n=24) were enrolled, mean of age 26.17 (18-39) years old, normal body weight, mean body mass index of 20.58 (18.07-24.73) kg/m2. Twenty two subjects were completed the study. Data from 22 subjects were included in the pharmacokinetic and statistical analysis. After oral administration of Gliclazide 60 mg, the mean of maximum plasma concentration (Cmax) 2104.05 (1018.66).
The ratio was 109.60% (99.61-120.59)%, AUC 0-t 104.28% (92.07-118.11)%, and for AUC 0-∞ 102.95% (90.67 - 116.88)%. Therefore it can be concluded that the test product, Gliclazide 60 mg modified release tablet, is bioequivalence with the reference product.
