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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date15 Apr 2020 |
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Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ CompletedNot Applicable 沙库巴曲缬沙坦钠片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of sacubitril-valsartan sodium tablets in healthy volunteers under fasting and fed conditions
主要目的:本研究以四川美大康药业股份有限公司生产的沙库巴曲缬沙坦钠片为受试制剂,Novartis Pharma Schweiz AG持证的沙库巴曲缬沙坦钠片(商品名:诺欣妥)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 used sacubitril valsartan sodium tablets produced by Sichuan Meidakang Pharmaceutical Co., Ltd. as the test preparation and sacubitril valsartan sodium tablets (trade name: Nuxintu) certified by Novartis Pharma Schweiz AG 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: To observe the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable 达格列净二甲双胍缓释片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of dapagliflozin and metformin extended-release tablets in healthy volunteers under fasting and fed conditions
主要目的:本研究以四川美大康药业股份有限公司研制的达格列净二甲双胍缓释片为受试制剂,按生物等效性试验的有关规定,以AstraZeneca AB持证的Xigduo XR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 used dapagliflozin metformin sustained-release tablets developed by Sichuan Meidakang Pharmaceutical Co., Ltd. as the test preparation. According to the relevant provisions of the bioequivalence test, Xigduo XR certified by AstraZeneca AB was used as the reference preparation. The 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: To observe the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable 阿奇霉素分散片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of azithromycin dispersible tablets in healthy volunteers under fasting and fed conditions
主要目的:本研究以四川美大康药业股份有限公司持证的阿奇霉素分散片(规格:0.25g)为受试制剂,按生物等效性试验的有关规定,以Teva Nederland B.V.持证的阿奇霉素片(商品名:AZITROMYCINE 250MG TEVA,规格:250mg)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 azithromycin dispersible tablets (specification: 0.25g) certified by Sichuan Meidakang Pharmaceutical Co., Ltd. as the test preparation, and azithromycin tablets (trade name: AZITROMYCINE 250MG TEVA, specification: 250mg) certified by Teva Nederland B.V. as the reference preparation according to the relevant provisions of the bioequivalence test. Human bioequivalence tests are 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 Sichuan Medco Pharmaceutical Stock Co., Ltd.
0 Patents (Medical) associated with Sichuan Medco Pharmaceutical Stock Co., Ltd.
100 Deals associated with Sichuan Medco Pharmaceutical Stock Co., Ltd.
100 Translational Medicine associated with Sichuan Medco Pharmaceutical Stock Co., Ltd.