美阿沙坦钾片在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床试验
[Translation] A human bioequivalence clinical trial of Asartan Potassium Tablets in Chinese healthy subjects after single administration under fasting and fed conditions
主要目的：以持证商为Takeda Pharma A/S的美阿沙坦钾片（商品名：易达比®（EDARBI®），规格：按美阿沙坦（C30H24N4O8）计80mg）为参比制剂，以杭州端本医药科技有限公司研发的美阿沙坦钾片（规格：80mg）为受试制剂，评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the two preparations in healthy Chinese subjects in the fasting and postprandial state, using the reference preparation of edartan potassium tablets (trade name: EDARBI®, specification: 80 mg based on edartan (C30H24N4O8)) developed by Takeda Pharma A/S as the reference preparation and the test preparation of edartan potassium tablets (specification: 80 mg) developed by Hangzhou Duanben Pharmaceutical Technology Co., Ltd. as the test preparation.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
氟比洛芬凝胶贴膏在中国健康受试者外用条件下单次给药的人体生物等效性临床试验
[Translation] A human bioequivalence clinical trial of flurbiprofen gel patch in Chinese healthy volunteers after single administration under topical conditions
主要目的：
以持证商为MIKASA SEIYAKU CO.,LTD的氟比洛芬凝胶贴膏（每贴含氟比洛芬40mg（面积13.6cm×10.0cm，含膏量12g），商品名为泽普思® （Zepolas®））为参比制剂，以杭州端本医药科技有限公司研制的氟比洛芬凝胶贴膏（每贴（面积13.6cm×10.0cm）含膏体12g，含氟比洛芬40mg）为受试制剂，评价两种制剂在中国健康受试者中外用条件下的生物等效性。
次要目的： 1）评价受试制剂与参比制剂在中国健康受试者中的安全性；
2）评价受试制剂与参比制剂在中国健康受试者用药过程中的粘附性；
3）评价受试制剂与参比制剂对中国健康受试者的皮肤反应性。
[Translation] Main purpose:
Using the flurbiprofen gel patch (containing 40 mg of flurbiprofen per patch (area 13.6 cm × 10.0 cm, containing 12 g of paste), trade name Zepolas®) of the licensed manufacturer MIKASA SEIYAKU CO., LTD as the reference preparation, and the flurbiprofen gel patch (containing 12 g of paste per patch (area 13.6 cm × 10.0 cm), containing 40 mg of flurbiprofen) developed by Hangzhou Duanben Pharmaceutical Technology Co., Ltd. as the test preparation, the bioequivalence of the two preparations under topical conditions in Chinese healthy subjects was evaluated.
Secondary objectives: 1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects;
2) To evaluate the adhesion of the test preparation and the reference preparation during the medication process of Chinese healthy subjects;
3) To evaluate the skin reactivity of the test preparation and the reference preparation to Chinese healthy subjects.
双氯芬酸依泊胺贴在中国健康受试者外用条件下单次给药的人体生物等效性临床试验
[Translation] A human bioequivalence clinical trial of diclofenac epolamide patch in Chinese healthy volunteers after single administration under topical conditions
主要目的：
以持证商为Institut Biochimique SA的双氯芬酸依泊胺贴（规格：1.3%，10cm×14cm；商品名为：Flector）为参比制剂，以杭州端本医药科技有限公司研制的双氯芬酸依泊胺贴 [规格：每贴（14cm×10cm）含双氯芬酸依泊胺180mg，1.3%（每100g膏体中含双氯芬酸依泊胺1.3g）] 为受试制剂，评价两种制剂在中国健康受试者中外用条件下的生物等效性。
次要目的：
1）评价受试制剂与参比制剂在中国健康受试者中的安全性；
2）评价受试制剂与参比制剂在中国健康受试者用药过程中的粘附性；
3）评价受试制剂与参比制剂对中国健康受试者的皮肤反应性。
[Translation] Main purpose:
The diclofenac epolamide patch (specification: 1.3%, 10cm×14cm; trade name: Flector) of the licensee Institut Biochimique SA was used as the reference preparation, and the diclofenac epolamide patch [specification: each patch (14cm×10cm) contains 180mg diclofenac epolamide, 1.3% (each 100g of paste contains 1.3g diclofenac epolamide)] developed by Hangzhou Duanben Pharmaceutical Technology Co., Ltd. was used as the test preparation to evaluate the bioequivalence of the two preparations under topical conditions in Chinese healthy subjects.
Secondary objectives:
1) Evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects;
2) Evaluate the adhesion of the test preparation and the reference preparation during the medication process in Chinese healthy subjects;
3) Evaluate the skin reactivity of the test preparation and the reference preparation in Chinese healthy subjects.
100 Clinical Results associated with Hangzhou Duanben Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Hangzhou Duanben Pharmaceutical Technology Co., Ltd.
100 Deals associated with Hangzhou Duanben Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Hangzhou Duanben Pharmaceutical Technology Co., Ltd.
