Steady-state pharmacokinetics and bioequivalence study of quetiapine fumarate film-coated tablets 300 mg in adult schizophrenic patients

Madhava Rao Betha, S. Tippabhotla, Sandeep Yergude, Sohel Md. Khan, Mukesh Nakkawar, C. Gadiko, S. Thota, Raju Cheerla, R. Battula, V. Vobalaboina
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Abstract

Quetiapine is a dibenzothiazepine derivative approved for the treatment of schizophrenia and related psychoses. The objective of the present study was to design and evaluate the bioequivalence between quetiapine fumarate film-coated tablets of Dr. Reddy’s Laboratories Ltd., Hyderabad, India (test) and Seroquel® tablets (containing quetiapine) of AstraZeneca Pharmaceuticals LP Wilmington, DE, USA (reference). It was a two-way crossover steady-state multiple dose study in 54 adult schizophrenic patients under fasting conditions. Quetiapine was analyzed in plasma samples by using a validated liquid chromatographic mass spectrometry (LC-MS/MS) method. The pharmacokinetic parameters were estimated by noncompartmental method and mean (±SD) of Cmax,ss (ng/mL) for test and reference products were 1436.5 (±810.2) and 1413.1 (±905.5), respectively. The mean (±SD) of AUCτ,ss (ng·h/mL) for test and reference products were 6949.8 (±3879.8) and 6532.2 (±4279.4), respectively. The ratio of least square means and its 90% confidence interval for Cmax,ss and AUCτ,ss were found to be within bioequivalence limits 80.00–125.00%. In conclusion, test product was bioequivalent to the reference product in terms of both rate and extent of absorption under steady-state conditions.
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富马酸奎硫平膜包衣片300mg在成人精神分裂症患者体内的稳态药代动力学及生物等效性研究
喹硫平是一种二苯并噻唑类衍生物,被批准用于治疗精神分裂症和相关精神病。本研究的目的是设计和评价印度海得拉巴Dr. Reddy 's Laboratories Ltd.的富马酸喹硫平薄膜包衣片(试验)和美国阿斯利康制药公司(AstraZeneca Pharmaceuticals LP Wilmington, DE, USA)的思瑞康®片(含喹硫平)的生物等效性(参考)。这是一项对54名成年精神分裂症患者在禁食条件下进行的双向交叉稳态多剂量研究。采用经验证的液相色谱-质谱(LC-MS/MS)方法对血浆样品中的喹硫平进行分析。采用非区室法估计药代动力学参数,被试品和参比品Cmax、ss (ng/mL)均值(±SD)分别为1436.5(±810.2)和1413.1(±905.5)。被试品和参比品AUCτ、ss (ng·h/mL)的平均值(±SD)分别为6949.8(±3879.8)和6532.2(±4279.4)。Cmax,ss和AUCτ,ss的最小二乘平均值及其90%置信区间均在80.00-125.00%的生物等效性范围内。综上所述,在稳态条件下,试验品在吸收速率和吸收程度上与对照品具有生物等效性。
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