/ CompletedNot Applicable [Translation] Bioequivalence Study of Enteric-coated Aspirin Tablets
主要目的:在健康受试者体内,分别在空腹和餐后条件下,以Bayer S.p.A持有的阿司匹林肠溶片(商品名:拜阿司匹灵®;规格:100 mg)为参比制剂,研究乐普恒久远药业有限公司研制的阿司匹林肠溶片(规格:100 mg)的吸收速度与吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察健康受试者口服受试制剂、参比制剂的安全性。
[Translation] Primary objective: To study the absorption rate and extent of enteric-coated aspirin tablets (specification: 100 mg) developed by Lepu Hengjiuyuan Pharmaceutical Co., Ltd. in healthy subjects under fasting and postprandial conditions, using enteric-coated aspirin tablets (trade name: Bayer Aspirin®; specification: 100 mg) owned by Bayer S.p.A as the reference preparation, and to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary objective: To observe the safety of oral administration of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable [Translation] Bioequivalence study of valsartan capsules in humans
以乐普恒久远药业有限公司提供的缬沙坦胶囊为受试制剂,按生物等效性试验的有关规定,与北京诺华制药有限公司生产的缬沙坦胶囊(参比制剂,商品名:代文®;规格:80mg)对比在健康人体内空腹给药状态下的相对生物利用度,考察受试制剂与参比制剂的人体生物等效性。
[Translation] The valsartan capsules provided by Lepu Hengjiuyuan Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, the relative bioavailability of the valsartan capsules (reference preparation, trade name: Diovan®; specification: 80 mg) produced by Beijing Novartis Pharmaceuticals Co., Ltd. under the fasting administration state in healthy humans was compared to investigate the bioequivalence of the test preparation and the reference preparation.
/ CompletedNot Applicable [Translation] Bioequivalence study of valsartan capsules in humans
以乐普恒久远药业有限公司提供的缬沙坦胶囊为受试制剂,按生物等效性试验的有关规定,与北京诺华制药有限公司生产的缬沙坦胶囊(参比制剂,商品名:代文®;规格:80mg)对比在健康人体内空腹和餐后给药两种状态下的相对生物利用度,考察受试制剂与参比制剂的人体生物等效性。
[Translation] The valsartan capsules provided by Lepu Hengjiuyuan Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, the relative bioavailability of the valsartan capsules (reference preparation, trade name: Diovan®; specification: 80 mg) produced by Beijing Novartis Pharmaceuticals Co., Ltd. under the two states of fasting and postprandial administration in healthy humans was compared to investigate the bioequivalence of the test preparation and the reference preparation.
100 Clinical Results associated with Xinxiang Hengjiuyuan Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Xinxiang Hengjiuyuan Pharmaceutical Co. Ltd.
100 Deals associated with Xinxiang Hengjiuyuan Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Xinxiang Hengjiuyuan Pharmaceutical Co. Ltd.