利奈唑胺片(600 mg)在中国健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究
[Translation] A single-dose, randomized, open-label, two-cycle, double-crossover, fasting and postprandial bioequivalence study of linezolid tablets (600 mg) in Chinese healthy subjects
主要研究目的:以Pfizer Pharmaceuticals.LCC持证的利奈唑胺片(600 mg)为参比制剂,以浙江杭康药业有限公司研发的利奈唑胺片(600 mg)为受试制剂,通过单中心、单次给药、随机、开放、两周期、双交叉设计的临床研究来评价两种制剂在空腹和餐后状态下的人体生物等效性。
次要研究目的: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] Main research purpose: Use Pfizer Pharmaceuticals.LCC-certified linezolid tablets (600 mg) as the reference preparation, and linezolid tablets (600 mg) developed by Zhejiang Hangkang Pharmaceutical Co., Ltd. as the test preparation. A central, single-dose, randomized, open-label, two-cycle, double-crossover design clinical study was conducted to evaluate the human bioequivalence of the two formulations in the fasting and postprandial states.
Secondary research purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.
沙格列汀片在中国健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究
[Translation] A single-dose, randomized, open-label, two-cycle, double-crossover, fasting and postprandial bioequivalence study of saxagliptin tablets in Chinese healthy subjects
主要研究目的:以AstraZeneca AB持证的沙格列汀片(规格:5 mg,商品名:安立泽/ONGLYZA)为参比制剂,以浙江杭康药业有限公司生产的沙格列汀片(规格:5 mg)为受试制剂,通过单中心、单次给药、随机、开放、两周期、双交叉设计的临床研究来评价两种制剂在空腹和餐后状态下的人体生物等效性。
次要研究目的: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] Main research purpose: Take AstraZeneca AB’s certified saxagliptin tablets (specification: 5 mg, trade name: ONGLYZA) as the reference preparation, and saxagliptin tablets produced by Zhejiang Hangkang Pharmaceutical Co., Ltd. ( Specification: 5 mg) is the test preparation. The human bioequivalence of the two preparations in the fasting and postprandial states was evaluated through a single-center, single-dose, randomized, open-label, two-cycle, double-crossover design clinical study. .
Secondary research purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.
[Translation] Bioequivalence Study of Hydroxychloroquine Sulfate Tablets in Human
主要目的:采用单中心、随机、开放、单次给药、单周期平行试验设计,比较空腹和餐后给药条件下,浙江杭康药业有限公司生产的硫酸羟氯喹片(0.2 g)与Sanofi-aventis Ireland Ltd. T/A SANOFI持证的硫酸羟氯喹片(商品名:PLAQUENIL®,规格:0.2 g)在中国健康人群中吸收程度和吸收速度的差异,评价生物等效性。
次要目的:评价硫酸羟氯喹片(规格:0.2 g)受试制剂和参比制剂在健康受试者体内的安全性。
[Translation] Main purpose: Using a single-center, randomized, open, single-dose, single-period parallel trial design, compare the hydroxychloroquine sulfate tablets (0.2 g) produced by Zhejiang Hangkang Pharmaceutical Co., Ltd. Sanofi-aventis Ireland Ltd. T/A Sanofi-licensed hydroxychloroquine sulfate tablets (trade name: PLAQUENIL®, specification: 0.2 g) in Chinese healthy population differs in absorption degree and absorption speed, and evaluates bioequivalence.
Secondary purpose: To evaluate the safety of hydroxychloroquine sulfate tablets (specification: 0.2 g) test preparation and reference preparation in healthy subjects.
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