This Phase I clinical trial aimed to address the knowledge gap regarding topiroxostat's use outside Japan by characterizing its pharmacokinetic profile, safety, and efficacy in healthy Chinese subjects.

Methods::

The trial followed a randomized, open-label, three-dose group design, enrolling 12 healthy participants and administering topiroxostat at three different dose levels. The study utilized NONMEM software for pharmacokinetic analysis, evaluating the impact of demographic and biochemical covariates on drug disposition.

Results::

Pharmacokinetic analysis shows the peak drug concentration (Cmax) under a single oral administration of 20, 40, and 80 mg of Topiroxostat, which was found in healthy subjects to be 215.46 ± 94.04 ng/mL, 473.74 ± 319.83 ng/mL and 1009.63 ± 585.98 ng/mL, respectively. The time to peak drug concentration (Tmax) was longer in females (0.79–0.98 h) than in males (0.53–0.93 h). Activated partial thromboplastin time (APTT) and triglycerides (TG) were included as covariates for the typical value of the absorption rate constant (TVKA) in our pharmacokinetic model. The dose (DOSE) was considered a covariate for the typical value of bioavailability (TVF1), and sex (SEX) was considered a covariate for the typical value of clearance (TVCL). The typical population values for topiroxostat included Q/F at 4.91 L/h, KA at 0.657 h-¹, Vc/F at 32.5 L, Vp/F at 30 L, and CL/F at 124 L/h.

Conclusion::

The trial successfully established the pharmacokinetic parameters of topiroxostat in a Chinese population, confirming its safety and efficacy. The results support the need for individualized dosing strategies and optimize therapeutic outcomes.

Drug design, development and therapy3区 · 医学

Pharmacokinetic Study of Frovatriptan Succinate Tablet After Single and Multiple Oral Doses in Chinese Healthy Subjects

3区 · 医学

ArticleOA

作者: Xia, Yan ; Fan, Hongwei ; Qu, Shengjun ; Zhang, Jingjing ; Ma, Zhixiang ; Fan, Lin ; Zheng, Hongquan ; Chen, Yangsheng

PURPOSE:

The present report describes findings from a Phase I clinical study that evaluated the single- and multiple-dose pharmacokinetics of frovatriptan succinate tablet in Chinese healthy subjects.

METHODS:

A total of 24 healthy subjects were enrolled. In single-dose study, 2.5, 5, and 10 mg oral doses of frovatriptan succinate tablet were administrated. A 2.5 mg frovatriptan succinate tablet was administrated 12 times in 7 days in the multiple-dose study. Blood samples were collected at scheduled time points.

RESULTS:

The results in single-dose study indicated that the blood levels were proportional to the administered dose, with the mean C_max and AUC_last ranging from approximately 6.27 ng/mL-17.35 ng/mL and 92.52 h⋅ng/mL - 287.40 h⋅ng/mL over the dose range. In the multiple-dose study, moderate drug accumulation was noted, which was attributable to forvatriptan's long t_1/2 of about 26.47 to 30.63 h. Gender differences were noticed in both single- and multiple-dose study; exposure PK parameters were consistently higher in female than in male.

CONCLUSION:

These pharmacokinetic evaluations in healthy Chinese subjects found that frovatriptan succinate tablet has an acceptable pharmacokinetic profile in Chinese subjects.

Liaoning Zhongyi Zazhi

Astragalosides extract on pharmacokinetics and tissue distribution in rats

作者: Wang, Xin ; Zhang, Zhenqiu

Objective: To establish methods for determining Astragaloside IV in rats plasm by HPLC-UV and study the pharmacokinetics and tissue distribution of Astragaloside IV in rats.Methods: The rats blood was collected in 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24 h after garaged 0.0022 g·kg^-1 Astragalosides extractEach rat had been garaged 3.5 mL.The rats were executed after collecting blood and tissue samples were collected before garaged (0 h), 0. 5, 1, 2 h after garaged 0.0022 g·kg^-1 Astragalosides extract which included heart, liver, spleen, stomach, kidney, lung, large intestine, small intestine and other groups.The concentrations of Astragaloside IV in plasma and tissues were determined by HPLC.Results: Astragaloside IV of Astragalosides extract metabolism in plasma was found to be active during pharmacokinetic study.Medication had longer survival time than blank rats in process of blood collection.Astragaloside IV assay of Astragalosides extract metabolism in tissues after 1 h from high to low were: liver > small intestine > lung > heart > stomach > large intestine > spleen > kidney.Conclusion: Astragalosides extract has active cardiotonic effect, being consistent with radix astragali effect of invigorating Qi for consolidating superficies.Astragaloside IVof Astragalosides extract metabolism in tissues after 1 h from high to low shows higher levels in the lung, which is accorded with radix astragali tropism.

项与江苏礼华生物技术有限公司相关的新闻（医药）

2021-07-15

·药事纵横

中国原创新药萌芽时代：致敬生物医药创新者

2020年，第一届新药创新者峰会在天府之国成都召开，汇聚了1200多全国嘉宾共议新药研发，彼时我们就新药研发新技术，新药成药性分析为主题邀请了68位嘉宾分享经验和观点。有人说是结构新颖，有人说是靶点清奇，也有人说需要商业模式群而不同。药融圈认为，创新不在乎大小，也不是为了新而新，终极目的是采用创新手段加速药物上市，解决现有未满足的临床用药需求，以这一目的为导向的各个阶段的创新都存在巨大的价值，涵盖技术，策略，商业及人。 “致敬生物医药创新者”是药融圈未来5年的主题，将是我们工作的核心价值观，也是对新药创新者的敬畏与尊重。这次，我们将从创新药注册及临床研究经验，药物发现与评价策略，选题立项的思考等方面邀请一线实战专家就相应话题分享他们的经验和看法，以期能够为与会嘉宾带来灵感，共同助力中国生物医药产业腾飞。主办单位 | 药融圈、新华日报社苏州分社、Chemenu®论坛时间 | 2021年8月10-11日论坛地点 | 苏州国际博览中心D馆论坛参会 | 限时免费预登记报名（现场注册100元） ▲立刻扫码，限时免费参会会议日程会议日程以最终版本为准 9:30-10:00医药企业的合作趋势及项目选择的策略周峰，海思科，国际合作部负责人 10:00-10:30下一个生命科技的热门领域：生物相变谢雨礼，苏州偶领，总经理 10:30-11:00创新药企如何构建和评估商业化能力刘谦，阿斯利康中国，副总裁 11:00-11:30差异化竞争的立项思路：如何避免靶点扎堆党群，河南真实生物，总裁 11:30-12:00小分子创新药的立项案例分享(拟）赵立文，南京圣和药业，研究院院长 12:00-13:30午餐 13:30-14:00创新药开发策略的几点思考及在投资和BD中的实践吴宏忠，麦科奥特，副总裁 14:00-14:30小分子药物开发热门靶标及全球研发现状王中健，药融云，总经理 14:30-15:00PROTAC技术在新药研发中的应用Jialiang Wang, Cullgen, VP 15:00-15:30创新药研发中的知识产权问题王颖，立方律师事务所，合伙人 15:30-16:20圆桌讨论：小分子创新药研发中的“坑”夏明德，英诺湖医药，CEO万昭奎，凌科药业，董事长王中健，药融云，总经理王颖，立方律师事务所，合伙人谢雨礼，苏州偶领，总经理 9:30-9:55创新药研发的全球注册策略与思考闫小军，百济神州，副总裁 9:55-10:20国内新药研发现状分析陈霞，北京天坛医院，研究员 10:20-10:45临床研究中的药物警戒管理潘丽怡，北京新领先，临床事业部总经理助理兼运营部总监 10:45-11:10申办者如何实现“以患者为中心，以科学为基础”的提高抗肿瘤创新药开发成功策略郭东升，科临达康医药，创始人 11:10-11:35创新药早期临床试验的探索与挑战程泽能，慧泽医药，董事长&CSO 11:35-12:00从立项开始：抗肿瘤创新药的临床开发策略及生命周期管理杨修诰，石药集团，医学总监 12:00-13:30午餐 13:30-13:55临床试验失败的主要原因分析及注意事项夏燕，江苏礼华生物，总经理 13:55-14:20主题待定(正在邀请)蒋殷睿，百时美施贵宝，医学总监 14:20-14:45如何有效规避临床试验责任风险祝昌峰，众诚保险，总经理 14:45-15:10临床试验的数据处理及统计分析李伟东，和铂医药，高级副总裁 15:10-15:35创新药物相互作用临床评价: 代谢酶介导的药物相互作用临床试验方案设计丁黎，中国药科大学，教授 15:35-16:00定量药理学在新药研发中的应用刘李，中国药科大学，教授 9:30-9:55新药成药性分析的思考与实践郭建军，湖南恒兴医药， CEO 9:55-10:20新药研发中晶型研究的作用陈岑，苏州晶云药物，高级总监 10:20-10:45Solution engine 2.0 – 难溶化合物快速增溶技术平台李红，保诺桑迪亚，制剂部负责人 10:45-11:10上市后变更管理王茂林，江西博腾药业，副总经理 11:10-11:35创新药的毒理及安全性评价关键点扈正桃，成都华西海圻，副总经理 11:35-12:00新药研发过程中的动物模型选择要点江万祥，四川格林泰科，副总经理 12:00-13:30午餐 13:30-13:55浅谈ADC药物发展创新之路彭立军，上海皓元医药，副总裁 13:55-14:20制剂技术助力创新药物研发李伟，广州玻思韬，制剂副总裁 14:20-14:45绿色合成工艺在药物分子的创新与开发李晓迅，四川青木制药，首席科学家 14:45-15:10结构解析新技术MicroED加速新药发现刘磊峰，苏州青云瑞晶，CEO 15:10-15:35PEG化技术-长效蛋白修饰外的新应用王庆彬，北京键凯科技，研发总监 15:35-16:20圆桌讨论：小分子药物发现与评价的难点参会报名参会：限时免费（本次报名为预登记报名，报名审核通过后将由药融圈秘书处通知您）报名参会咨询：会务组1：13306586060（微信同号）会务组2：15706844213（微信同号）会务组3：18801970633（微信同号）立刻扫码限时免费参会8.10-11·苏州商务合作展位火热抢定中可为生物药/化学药相关新药/仿制药药学研发机构CRO/CDMO、临床用药生产基地、CMO/MAH生产承接企业、临床试验机构、第三方稽查机构、制药装备企业、辅料生产/代理机构、注册咨询机构、海外药品研发机构、临床试验机构、杂质对照品、参比制剂、第三方检测机构、实验室工程、实验室设备、分析设备、生产设备、知识产权等企业提供多形式的宣传展示。设展、演讲等商务合作福利、收费标准等详情请咨询主办方：周慧芬 15858667450 张玲 15057280775赖庆刚 13550291524同期论坛，火热报名中☞2021生物医药创新国际化领跑者论坛☞免疫江湖：细胞和基因疗法论坛☞百抗风云：抗体药专场论坛☞核酸崛起：核酸药物与疫苗专场☞中国AI新药合作大会☞API Summit 第二届中国原料药企业家年会大会组织架构❖以下支持单位仅部分，持续更新中... 戳原文报名第三届中国国际生物&化学制药产业大会

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