Pharmacokinetics Study of Pioglitazone (30 mg) Tablets in Healthy Volunteers

Abstract

Pioglitazone, an excellent insulin sensitizer, is used for the treatment of type 2 diabetes mellitus
(T2DM). The present investigation demonstrated a single dose pharmacokinetic study of pioglitazone tablet in 24
healthy male volunteers in a randomized protocol. Blood samples were collected before and 0.5 to 24.0 h after a
single oral dose of a 30 mg pioglitazone tablet. Plasma pioglitazone level was determined using a validated method of
reversed phase binary high performance liquid chromatography (HPLC). The pharmacokinetic parameters
determined were 1.117 ± 0.315 (μg/ml), 2.5 ± 0.735 (h), 9.014 ± 3.385 (μg.h/ml), 8.081 ± 3.407 (μg. h/ml), 1.315 ±
0.964 (h), 0.707 ± 1.636 (h-1), 0.078 ± 0.02 (h-1) and 8.884 ± 03.808 (h) for Cmax, Tmax, AUC0-∞, AUC0-24, Ka, T1/2
(α), Kel, and T1/2(β), respectively. Variation of pioglitazone pharmacokinetic parameters in Bangladeshi population
compared to Chinese, Thai and German population may indicate the polymorphic variation in the pioglitazone
responsive metabolizing gene CYP3A4 and CYP2C19 in our population.