Bioequivalence study of a generic quetiapine in healthy male volunteers
W. Mahatthanatrakul, K. Rattana, S. Sriwiriyajan, M. Wongnawa, W. Ridtitid
Department of Pharmacology, Faculty of Science, Prince of Songkla University, Songkhla, Thailand
DOI 10.5414/CPP46489
Abstract
Aim: To study the bioequivalence of a generic quetiapine (Quantia 200®, manufactured by the Unison Laboratories Co., Ltd., Bangkok, Thailand) and the innovator product (Seroquel®, 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® 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-µ) of Quantia 200® vs. Seroquel® 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 × h/ml and 4,015.35 ± 1,528.25 vs. 3,769.45 ± 1,296.69 ng × h/ml, respectively. Time to reach Cmax (tmax) of Quantia 200® and Seroquel® 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-µ 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-µ was 92.1%, 96.9% and 97.4%, respectively. Conclusion: Quantia 200®, used in this study, was bioequivalent to Seroquel® in terms of both the rate and extent of absorption.
Author Details
Authors
Departments
- Department of Pharmacology, Faculty of Science, Prince of Songkla University, Songkhla, Thailand
Address
Dr. W. Mahatthanatrakul, MD, FCFPT; Department of Pharmacology, Faculty of Science, Prince of Songkla University, Hat Yai, Songkhla, 90112, Thailand
Email:
[email protected]
Citation
W. Mahatthanatrakul, K. Rattana, S. Sriwiriyajan, M. Wongnawa and W. Ridtitid .Bioequivalence study of a generic quetiapine in healthy male volunteers . 2008; 46: 489-496. doi: 10.5414/CPP46489.
