以杭州仟源保灵药业有限公司生产的培哚普利氨氯地平片（II）（规格：5 mg/10 mg ）为受试制剂，以Les Laboratoires Servier的培哚普利氨氯地平片（II）（开素达®，规格：5 mg/10 mg ）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

开始日期2024-07-30

申办/合作机构

杭州澳医保灵药业有限公司

CTR20241321 / CompletedN/A

依伏卡塞片人体生物等效性试验

以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定杭州仟源保灵药业有限公司研制的依伏卡塞片（规格：2 mg）给药后依伏卡塞在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以协和麒麟株式会社持证和生产的依伏卡塞片(规格：2 mg，商品名：Orkedia®)为参比制剂，考察受试制剂的相对生物利用度，评价制剂间的生物等效性，并观察受试制剂和参比制剂在中国健康受试者中的安全性。

开始日期2024-04-21

申办/合作机构

杭州澳医保灵药业有限公司

CTR20230504 / CompletedN/A

一项单中心、随机、开放、单次给药、两制剂、两周期交叉设计研究评价杭州仟源保灵药业有限公司的精氨酸培哚普利片与Les Laboratoires Servier的精氨酸培哚普利片在健康受试者中的空腹和餐后状态下的生物等效性研究

主要研究目的：评价杭州仟源保灵药业有限公司的精氨酸培哚普利片与Les Laboratoires Servier的精氨酸培哚普利片空腹和餐后单次口服给药后在健康人群中的生物等效性。次要研究目的：评价受试制剂和参比制剂在健康人群中的安全性。

开始日期2023-02-13

申办/合作机构

杭州澳医保灵药业有限公司

100 项与杭州澳医保灵药业有限公司相关的临床结果

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0 项与杭州澳医保灵药业有限公司相关的专利（医药）

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项与杭州澳医保灵药业有限公司相关的文献（医药）

2022-07-01·Journal of Zhejiang University-SCIENCE B

Detection, isolation, and characterization of a novel impurity from several folic acid products

Article

作者: Shen, Qirong ; He, Quan ; Pan, Yuanjiang ; Sun, Cuirong

Folic acid belongs to the group of water-soluble B vitamins and naturally exists in multiple forms in a wide variety of foods such as legumes, vegetables, liver, and milk (Iyer and Tomar, 2009; Lyon et al., 2020). It is involved in many biochemical reactions critical for cell division, such as purine and pyrimidine biosynthesis, DNA/RNA biosynthesis, and amino acid metabolism (Iyer and Tomar, 2009). Mammals cannot synthesize folic acid and thus they must acquire it from food. Although folic acid is ubiquitous in foods, folic acid deficiency still often occurs due to various causes such as unhealthy diet (Hildebrand et al., 2021; Iimura et al., 2022), disease-related malabsorption (Arcot and Shrestha, 2005), medication-related depletion (Arcot and Shrestha, 2005), or vitamin B12 deficiency (Fishman et al., 2000). Folic acid deficiency has been associated with several health problems, such as anemia (Carmel, 2005; Bailey and Caudill, 2012), cancer (Duthie, 1999), cardiovascular diseases (Wald et al., 2002), neural tube defects in newborns (van der Put et al., 2001), neuropsychiatric dysfunction (Shea et al., 2002), depression (Falade et al., 2021), inflammatory diseases (Suzuki and Kunisawa, 2015; Jones et al., 2019), and eye diseases (Sijilmassi, 2019). To prevent folic acid deficiency, its daily intake (400 μg/d) has been recommended for adults in the European Union, and its increased intake (600 μg/d) is advised for women before and during pregnancy (FAO/WHO, 2002; IOM, 2004). The New Zealand government mandated the fortification of non-organic wheat flour with folic acid in July 2021, and the UK government mandated the fortification of non-wholemeal wheat flour with folic acid in September 2021 (Haggarty, 2021).

100 项与杭州澳医保灵药业有限公司相关的药物交易

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100 项与杭州澳医保灵药业有限公司相关的转化医学

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