Zhengzhi Liu, Jinling Xue, Qiaohuan Deng, Yanli Wang, Lixiu Zhang, Lang Liu, Nan Xiao, Tianying Chang, Yingzi Cui, Yang Cheng, Guangwen Liu, Wanhua Wang, Yannan Zhou, Wei Yang, Xinyao Qu, Jiahui Chen, Yicheng Zhao, Zeyu Wang, Haimiao Yang
{"title":"新型鲁拉西酮仿制药的药代动力学和安全性：针对中国健康受试者的 I 期生物等效性研究","authors":"Zhengzhi Liu, Jinling Xue, Qiaohuan Deng, Yanli Wang, Lixiu Zhang, Lang Liu, Nan Xiao, Tianying Chang, Yingzi Cui, Yang Cheng, Guangwen Liu, Wanhua Wang, Yannan Zhou, Wei Yang, Xinyao Qu, Jiahui Chen, Yicheng Zhao, Zeyu Wang, Haimiao Yang","doi":"10.1007/s00210-024-03055-1","DOIUrl":null,"url":null,"abstract":"<p>Latuda<sup>®</sup> is a novel antipsychotic drug for schizophrenia and bipolar depression. A bioequivalence trial was performed to investigate the bioequivalence of Latuda<sup>®</sup> and its generic drug lurasidone. Two independent trials were carried out, each involving 28 subjects. In the fasting trial, subjects were randomly assigned to two groups (1:1 ratio), receiving either 40 mg of generic lurasidone or Latuda<sup>®</sup>. After a 7-day washout period, subjects entered the second period with a crossover administration of 40 mg of generic lurasidone or Latuda<sup>®</sup>. The postprandial study design was similar to that of the fasting study. In the fasting study, the pharmacokinetic (PK) parameter values of generic lurasidone and Latuda<sup>®</sup> were as follows: the <i>C</i><sub>max</sub> was 28.84 ± 19.34 ng/ml and 28.22 ± 21.19 ng/ml, respectively; the AUC<sub>0-t</sub> was 121.39 ± 58.47 h*ng/ml and 118.35 ± 52.24 h*ng/ml, respectively; and the AUC<sub>0-∞</sub> was 129.63 ± 63.26 h*ng/ml and 126.59 ± 57.99 h*ng/ml, respectively. The primary pharmacokinetic parameter, <i>C</i><sub>max</sub>, was assessed for equivalence using reference-scaled average bioequivalence (RSABE), while other parameters (AUC<sub>0-t</sub>, AUC<sub>0-∞</sub>) were evaluated using average bioequivalence (ABE). The results indicate that both <i>C</i><sub>max</sub> and AUC meet the equivalence criteria. In the postprandial study, the PK values of generic lurasidone and Latuda<sup>®</sup> were as follows: the <i>C</i><sub>max</sub> was 74.89 ± 32.06 ng/ml and 83.51 ± 33.52 ng/ml, respectively; the AUC<sub>0-t</sub> was 274.77 ± 103.05 h*ng/ml and 289.26 ± 95.25 h*ng/ml, respectively; and the AUC<sub>0-∞</sub> was 302.44 ± 121.60 h*ng/ml and 316.32 ± 109.04 h*ng/ml, respectively. The primary pharmacokinetic parameters (<i>C</i><sub>max</sub>, AUC<sub>0-t</sub>, AUC<sub>0-∞</sub>) were assessed for equivalence using ABE, and both met the equivalence criteria. In the study, lurasidone and Latuda<sup>®</sup> both exhibited acceptable safety and tolerability. The results displayed that lurasidone and Latuda<sup>®</sup> were bioequivalent and safe in healthy Chinese participants. Clinical Trial Registry: This trial is registered at chinadrugtrials.org.cn (no.: CTR20191717, date: 2019.08.29).</p>","PeriodicalId":18862,"journal":{"name":"Naunyn-schmiedebergs Archives of Pharmacology","volume":"6 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Pharmacokinetics and safety of a new generic lurasidone: a phase I bioequivalence study in healthy Chinese subjects\",\"authors\":\"Zhengzhi Liu, Jinling Xue, Qiaohuan Deng, Yanli Wang, Lixiu Zhang, Lang Liu, Nan Xiao, Tianying Chang, Yingzi Cui, Yang Cheng, Guangwen Liu, Wanhua Wang, Yannan Zhou, Wei Yang, Xinyao Qu, Jiahui Chen, Yicheng Zhao, Zeyu Wang, Haimiao Yang\",\"doi\":\"10.1007/s00210-024-03055-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>Latuda<sup>®</sup> is a novel antipsychotic drug for schizophrenia and bipolar depression. A bioequivalence trial was performed to investigate the bioequivalence of Latuda<sup>®</sup> and its generic drug lurasidone. Two independent trials were carried out, each involving 28 subjects. In the fasting trial, subjects were randomly assigned to two groups (1:1 ratio), receiving either 40 mg of generic lurasidone or Latuda<sup>®</sup>. After a 7-day washout period, subjects entered the second period with a crossover administration of 40 mg of generic lurasidone or Latuda<sup>®</sup>. The postprandial study design was similar to that of the fasting study. In the fasting study, the pharmacokinetic (PK) parameter values of generic lurasidone and Latuda<sup>®</sup> were as follows: the <i>C</i><sub>max</sub> was 28.84 ± 19.34 ng/ml and 28.22 ± 21.19 ng/ml, respectively; the AUC<sub>0-t</sub> was 121.39 ± 58.47 h*ng/ml and 118.35 ± 52.24 h*ng/ml, respectively; and the AUC<sub>0-∞</sub> was 129.63 ± 63.26 h*ng/ml and 126.59 ± 57.99 h*ng/ml, respectively. The primary pharmacokinetic parameter, <i>C</i><sub>max</sub>, was assessed for equivalence using reference-scaled average bioequivalence (RSABE), while other parameters (AUC<sub>0-t</sub>, AUC<sub>0-∞</sub>) were evaluated using average bioequivalence (ABE). The results indicate that both <i>C</i><sub>max</sub> and AUC meet the equivalence criteria. In the postprandial study, the PK values of generic lurasidone and Latuda<sup>®</sup> were as follows: the <i>C</i><sub>max</sub> was 74.89 ± 32.06 ng/ml and 83.51 ± 33.52 ng/ml, respectively; the AUC<sub>0-t</sub> was 274.77 ± 103.05 h*ng/ml and 289.26 ± 95.25 h*ng/ml, respectively; and the AUC<sub>0-∞</sub> was 302.44 ± 121.60 h*ng/ml and 316.32 ± 109.04 h*ng/ml, respectively. The primary pharmacokinetic parameters (<i>C</i><sub>max</sub>, AUC<sub>0-t</sub>, AUC<sub>0-∞</sub>) were assessed for equivalence using ABE, and both met the equivalence criteria. In the study, lurasidone and Latuda<sup>®</sup> both exhibited acceptable safety and tolerability. The results displayed that lurasidone and Latuda<sup>®</sup> were bioequivalent and safe in healthy Chinese participants. Clinical Trial Registry: This trial is registered at chinadrugtrials.org.cn (no.: CTR20191717, date: 2019.08.29).</p>\",\"PeriodicalId\":18862,\"journal\":{\"name\":\"Naunyn-schmiedebergs Archives of Pharmacology\",\"volume\":\"6 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-04-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Naunyn-schmiedebergs Archives of Pharmacology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s00210-024-03055-1\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Naunyn-schmiedebergs Archives of Pharmacology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s00210-024-03055-1","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Pharmacokinetics and safety of a new generic lurasidone: a phase I bioequivalence study in healthy Chinese subjects
Latuda® is a novel antipsychotic drug for schizophrenia and bipolar depression. A bioequivalence trial was performed to investigate the bioequivalence of Latuda® and its generic drug lurasidone. Two independent trials were carried out, each involving 28 subjects. In the fasting trial, subjects were randomly assigned to two groups (1:1 ratio), receiving either 40 mg of generic lurasidone or Latuda®. After a 7-day washout period, subjects entered the second period with a crossover administration of 40 mg of generic lurasidone or Latuda®. The postprandial study design was similar to that of the fasting study. In the fasting study, the pharmacokinetic (PK) parameter values of generic lurasidone and Latuda® were as follows: the Cmax was 28.84 ± 19.34 ng/ml and 28.22 ± 21.19 ng/ml, respectively; the AUC0-t was 121.39 ± 58.47 h*ng/ml and 118.35 ± 52.24 h*ng/ml, respectively; and the AUC0-∞ was 129.63 ± 63.26 h*ng/ml and 126.59 ± 57.99 h*ng/ml, respectively. The primary pharmacokinetic parameter, Cmax, was assessed for equivalence using reference-scaled average bioequivalence (RSABE), while other parameters (AUC0-t, AUC0-∞) were evaluated using average bioequivalence (ABE). The results indicate that both Cmax and AUC meet the equivalence criteria. In the postprandial study, the PK values of generic lurasidone and Latuda® were as follows: the Cmax was 74.89 ± 32.06 ng/ml and 83.51 ± 33.52 ng/ml, respectively; the AUC0-t was 274.77 ± 103.05 h*ng/ml and 289.26 ± 95.25 h*ng/ml, respectively; and the AUC0-∞ was 302.44 ± 121.60 h*ng/ml and 316.32 ± 109.04 h*ng/ml, respectively. The primary pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞) were assessed for equivalence using ABE, and both met the equivalence criteria. In the study, lurasidone and Latuda® both exhibited acceptable safety and tolerability. The results displayed that lurasidone and Latuda® were bioequivalent and safe in healthy Chinese participants. Clinical Trial Registry: This trial is registered at chinadrugtrials.org.cn (no.: CTR20191717, date: 2019.08.29).
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