Bioequivalence Study of A Generic Quetiapine in Healthy Male Volunteers
K Rattana, M Wongnawa, S Sriwiriyajan, W Mahatthanatrakul*, W RidtitidDepartment of Pharmacology, Prince of Songkla University, Songkhla, Thailand. [email protected]
บทคัดย่อ
Aim: To study the bioequivalence of a generic quetiapine (Quantia 200(R), manufactured by the Unison Laboratories Co., Ltd., Bangkok, Thailand) and the innovator product (Seroquel(R), AstraZeneca, Macclesfield, UK). Volunteers and methods: The study was a randomized, 2-way crossover design with a 2-week washout period in 24 healthy Thai male volunteers. After a single 200 mg oral dosing, serial blood samples were collected at appropriate interval up to 48 h. Plasma quetiapine concentrations were determined by high-performance liquid chromatography (HPLC). Pharmacokinetic parameters were estimated using the WinNonlin(R) software with noncompartment model analysis. Comparative bioequivalence between the two formulations was determined by analysis of variance (ANOVA) for 2-way crossover design. Results: The mean +/- SD of maximum plasma concentration (Cmax), the area under the plasma concentration-time curve from 0 - 48 h (AUC0-48) and the area under the plasma concentration-time curve from 0 to infinity (AUC0-inf) of Quantia 200(R) vs. Seroquel(R) were 886.60 +/- 356.50 vs. 811.34 +/- 323.37 ng/ml; 3,754.41 +/- 1,453.00 vs. 3,420.00 +/- 1,229.6 ng x h/ml and 4,015.35 +/- 1,528.25 vs. 3,769.45 +/- 1,296.69 ng x h/ml, respectively. Time to reach Cmax (tmax) of Quantia 200(R) and Seroquel(R) were 1.08 +/- 0.778 and 1.10 +/- 0.79 h, respectively, and thus not significantly different. The 90% confidence interval of the ratios of the logarithmically transformed of Cmax, AUC0-48 and AUC0-inf were 98.21 - 124.37%, 94.43 - 117.03% and 94.77 - 116.61%, respectively, which were within the acceptable range of 80 - 125%. Power of the test for Cmax, AUC0-48 and AUC0-inf was 92.1%, 96.9% and 97.4%, respectively. Conclusion: Quantia 200(R), used in this study, was bioequivalent to Seroquel(R) in terms of both the rate and extent of absorption.
ที่มา
International Journal of Clinical Pharmacology and Therapeutics ปี 2551, September
ปีที่: 46 ฉบับที่ 9 หน้า 489-496