/ RecruitingNot Applicable 恩格列净片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of empagliflozin tablets in healthy volunteers under fasting/fed conditions
主要目的:本研究以郑州韩都药业集团有限公司持证的恩格列净片(规格:25mg)为受试制剂,Boehringer Ingelheim International GmbH持证的恩格列净片(商品名:Jardiance®,规格:25mg)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: This study uses the empagliflozin tablets (specification: 25 mg) certified by Zhengzhou Handu Pharmaceutical Group Co., Ltd. as the test preparation and the empagliflozin tablets (trade name: Jardiance®, specification: 25 mg) certified by Boehringer Ingelheim International GmbH as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
Secondary purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable 盐酸奥洛他定片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of olopatadine hydrochloride tablets in healthy volunteers under fasting and fed conditions
主要目的:本研究以郑州韩都药业集团有限公司持证的盐酸奥洛他定片为受试制剂,协和麒麟株式会社持证的盐酸奥洛他定片(商品名:Allelock)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,
次要目的:评价受试制剂和参比制剂在健康受试者体内的生物等效性。
[Translation] Main purpose: This study used Olopatadine Hydrochloride Tablets certified by Zhengzhou Handu Pharmaceutical Group Co., Ltd. as the test preparation and Olopatadine Hydrochloride Tablets (trade name: Allelock) certified by Kyowa Kirin Co., Ltd. as the reference preparation to conduct a human bioequivalence test under fasting/fed conditions.
Secondary purpose: To evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable 吲哚布芬片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of indobufen tablets in healthy volunteers under fasting and fed conditions
主要目的:以郑州韩都药业集团有限公司持证的吲哚布芬片(规格:0.2g)为受试制剂,按生物等效性试验的有关规定,以Pfizer Italia S.r.l.持证的吲哚布芬片(商品名:Ibustrin,规格:0.2g)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Using the indobufen tablets (specification: 0.2g) certified by Zhengzhou Handu Pharmaceutical Group Co., Ltd. as the test preparation, and the indobufen tablets (trade name: Ibustrin, specification: 0.2g) certified by Pfizer Italia S.r.l. as the reference preparation, a human bioequivalence test was conducted under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
Secondary purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Zhengzhou Handu Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Zhengzhou Handu Pharmaceutical Co. Ltd.
100 Deals associated with Zhengzhou Handu Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Zhengzhou Handu Pharmaceutical Co. Ltd.