Abstract
This study was aimed to investigate bioequivalence of modified-release 30 mg gliclazide tablets in 18 healthy Thai volunteers. A test product, Glycon MR (Siam Bheasach, TH), was compared with a reference product, Diamicron MR (Servier, France). The study was performed under a single-dose, two-treatment, two-period, and two-sequence crossover design in fasted and fed conditions with a washout period of 2 weeks. Blood samples were collected for 72 h after drug administration. Drug plasma concentrations were determined by HPLC with a UV detector. Analysis of pharmacokinetic characteristics was based on a non-compartmental model. The logarithmically transformed data of Cmax and AUCs were analyzed for 90% confidence intervals using ANOVA. The test product gave slightly higher Cmax in both conditions and shorter Tmax in the fed condition. However, there is no significant difference in pharmacokinetic characteristics between both products under fasted and fed conditions. Effect of food was not significantly observed. The 90% confidence intervals were within the acceptance criteria of 0.80–1.25 regardless of the food effect, indicating bioequivalence between the two products on the rate and extent of gliclazide MR absorption without regard to meals.
Highlights
Gliclazide is a second-generation sulfonylurea, an oral hypoglycemic agent used in the treatment of noninsulin dependent diabetes mellitus
Group no. 1 was administered with the test product, following by the reference product whereas Group no. 2 started with the reference product, following by the test product
The results of this study demonstrated that the test product, Glycon MR, and the reference product, Diamicron MR were bioequivalent and may be used as an evidence for physicians to select the more cost-effective preparation of the modified-release gliclazide tablets
Summary
Gliclazide is a second-generation sulfonylurea, an oral hypoglycemic agent used in the treatment of noninsulin dependent diabetes mellitus. Long-term treatment of gliclazide improves insulin-mediated glucose utilization and potentiates the post-receptor insulin sensitive pathway [1, 2]. It may have advantages in reducing platelet aggregation and slowing the progression of diabetic retinopathy [3,4,5]. A new formulation of modified release gliclazide (Gliclazide MR) has been developed to a progressive delivery of the short acting gliclazide, intending to be administered once daily This formulation gains more interest as it gives better diabetic control and improves patient compliance [6, 7]
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