Pharmacokinetics and Bioequivalence of Two Combination Metformin/Glipizide Tablets under Fasting and Fed Conditions in Chinese Healthy Subjects: A Randomized, Open-Label, Crossover Study

Table 2

Main pharmacokinetic parameters of metformin and glipizide after a single dose of the test drug or reference drug under fasting and fed conditions.

PK parameter	Fasting		Fed
	Test (N = 23^a)	Reference (N = 24^a)	Test (N = 23^b)	Reference(N = 24)
Metformin
(ng/mL)	1227 ± 335	1251 ± 298	928 ± 278	947 ± 298
(h)^c	2.50 (0.50, 4.00)	2.38 (0.50, 4.00)	2.25 (1.00, 6.00)	2.75 (1.50, 7.00)
t1/2 (h)	4.4 ± 0.7	4.4 ± 0.6	4.3 ± 0.5	4.3 ± 0.7
AUC0-t (h∗ng/mL)	7198 ± 1630	7469 ± 1826	7041 ± 1800	7070 ± 1540
AUC0-∞ (h∗ng/mL)	7340 ± 1651	7357 ± 1416	7222 ± 1847	7253 ± 1572
Glipizide
(ng/mL)	226 ± 50	196 ± 42	234 ± 65	245 ± 57
(h)^c	4.00 (0.50, 5.50)	4.50 (1.50, 6.00)	2.50 (1.00, 5.50)	2.50 (1.50, 8.00)
t1/2 (h)	4.0 ± 0.6	4.0 ± 0.6	3.9 ± 0.7	3.9 ± 0.8
AUC0-t (h ng/mL)	1474 ± 946	1442 ± 865	1396.5 ± 288.7	1416 ± 353
AUC0-∞ (h ng/mL)	1318 ± 332	1302 ± 298	1426.8 ± 316.3	1447 ± 387

N, number of subjects; , maximum observed drug concentration in the plasma; , the time to attain following dose; t_1/2, terminal half-life of the analyte in the plasma; AUC_0-t, area under the plasma concentration-time curve from time 0 to the last sampling time; AUC_0-∞, area under the plasma concentration-time curve from time 0 to infinity. ^aOne subject withdrew from the period 2 without taking the test drug. ^bOne subject withdrew from the period 2 without taking the test drug. ^c (hour) is expressed as median (minimum, maximum).