Pharmacokinetics Study of Pioglitazone (30 mg) Tablets in Healthy Volunteers
نویسندگان
چکیده
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.
منابع مشابه
Bioequivalence study of 30 mg pioglitazone tablets in Thai healthy volunteers.
OBJECTIVE To compare the bioequivalent parameters of 30 mg pioglitazone tablets manufactured locally (Glista) and originally (Actos). MATERIAL AND METHOD A randomized, single dose, two-treatment, two-period, two-sequence crossover study was conducted Twenty-four healthy volunteers were recruited at Siriraj Clinical Research Unit. Each subject received a 30 mg pioglitazone tablet of both formu...
متن کاملPharmacokinetics and Bioequivalence study of Two Formulations of Cefixime in Healthy Male Volunteers
Cefixime is a significant member of orally active third generation cephalosporin and has excellent activity against many pathogens. The virtual bioavailability of a newly industrial dispersible tablet as compared with a recognized identified formulation. An open-label, single-dose, randomized, 2-way crossover study was conducted in fasted healthy Iranian male volunteers. Eligible participa...
متن کاملComparison of antiplatelet activity of garlic tablets with cardio-protective dose of aspirin in healthy volunteers: a randomized clinical trial
Objective: Some of the adverse effects of aspirin including peptic ulcers, gastrointestinal bleeding and aspirin resistance compelled researchers to find a suitable alternative with fewer adverse effects. In this clinical trial, we aimed to find the effective antiplatelet dose of garlic. Materials and Methods: This randomized controlled clinical trial (RCT) was conducted on 62 healthy volunteer...
متن کاملComparative study on the bioequivalence of two formulations of pioglitazone tablet in healthy Thai male volunteers.
The bioequivalence study of two 30 mg pioglitazone formulations was determined in healthy Thai male volunteers after a single dose administration in a randomized cross-over study with a 1-week washout period. Due to the high variability of the rate and extent of absorption of pioglitazone, an add-on subject study was required to assess bioequivalence. Reference product Actos, Takeda Chemical In...
متن کاملSafety Evaluation of Crocin (a constituent of saffron) Tablets in Healthy Volunteers
Objective(s): Crocin is the chemical ingredient primarily responsible for the color of saffron. It has different pharmacological effects such as antioxidant, anticancer and memory improving activities. Crocin tablets were evaluated for short-term safety and tolerability in healthy adult volunteers. Materials and Methods: The study was a randomized, double-blind, placebo-controlled design consis...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
دوره شماره
صفحات -
تاریخ انتشار 2015