Bioequivalence Study of Modified-Release Gliclazide Tablets in Healthy Volunteers

Table 2

Pharmacokinetic characteristics of gliclazide from 18 volunteers following a single oral administration of 30 mg gliclazide MR tablets under fasted condition.

Pharmacokinetic parameter	Products
	Test product; (Glycon MR)	Reference product; (Diamicron MR)
𝑇max (h)	8.22 ± 3.95	7.72 ± 1.96
𝐶max (ng/mL)	1,016.66 ± 283.48	898.67 ± 224.45
AUC0−𝑡 (ng·h/mL)	27,305.13 ± 10811.90	25,224.32 ± 11244.21
AUC0-∞ (ng·h/mL)	30,172.13 ± 13609.32	28,003.82 ± 13924.33
𝑡1/2 (h)	17.83 ± 5.40	15.50 ± 5.69
𝐾𝑒 (h^−1)	0.04 ± 0.01	0.04 ± 0.02