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
{"title":"Steady-state pharmacokinetics and bioequivalence study of quetiapine fumarate film-coated tablets 300 mg in adult schizophrenic patients","authors":"Madhava Rao Betha, S. Tippabhotla, Sandeep Yergude, Sohel Md. Khan, Mukesh Nakkawar, C. Gadiko, S. Thota, Raju Cheerla, R. Battula, V. Vobalaboina","doi":"10.3109/10601333.2012.740485","DOIUrl":null,"url":null,"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.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"57 1","pages":"65 - 71"},"PeriodicalIF":0.0000,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Research and Regulatory Affairs","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3109/10601333.2012.740485","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

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.
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
Changes to protocol in the regulation of adverse drug reactions – historical and current European view Policy and regulations in light of the human body as a ‘superorganism’ containing multiple, intertwined symbiotic relationships Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal Increasing the odds of effective drug development: Elevating regulatory affairs professionals to strategic partners Current regulatory challenges and approaches in the registration of herbal drugs in Europe
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1