生物学的同等性とバイオアベイラビリティのジャーナル

概要

Bioequivalence Study of Quetiapine 25 mg Tablets in Healthy Thai Volunteers under Fasting Conditions

Ekawan Yoosakul, Vipada Khaowroongrueng, Jaturavit Vattanarongkup, Charinthon Seeduang, Nava Suthepakul, Busarat Karachot, Isariya Techatanawat, Praphassorn Surawattanawan, Porranee Puranajoti

A comparative randomized, single-dose, two-way crossover, open-label study was carried out to assess bioequivalence and tolerability of test (Quapine^®) and reference (Seroquel^®) products of quetiapine 25 mg tablets in healthy Thai volunteers. Forty-four male and female subjects were enrolled in the study. Blood samples were collected at predefined time points over 48 hours after oral administration. Plasma concentrations of quetiapine were determined using a validated Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS). The pharmacokinetic parameters were calculated for the test and reference products using non-compartmental analysis. Bioequivalence between the products was determined by calculating 90% Confidence Intervals (CIs) for the geometric least squares mean ratio of log-transformed primary parameters (AUC_0-tlast, AUC_0-∞ and C_max) between the test and reference products. The 90% CIs were 96.08%-108.33% for AUC_0-tlast, 96.21%-108.31% for AUC_0-∞ and 96.52%-121.09% for C_max which were within the bioequivalence criteria of 80.00%-125.00%. The analysis of variance did not show any significant difference between the two formulations. Both formulations were generally well tolerated in Thai subjects. The incidence of adverse events after receiving the test and reference products was similar. Therefore, they can be used interchangeably, and the same efficacy and safety can be anticipated.