/ CompletedNot Applicable 苯溴马隆片(50 mg)空腹状态下在健康受试者中的生物等效性试验
[Translation] Bioequivalence study of benzbromarone tablets (50 mg) in healthy subjects under fasting condition
主要目的:在健康男性与女性受试者中于空腹条件下,评价受试制剂苯溴马隆片(规格:50 mg,生产商:浙江华海制药科技有限公司)和トーアエイヨー株式会社为持证商的参比制剂苯溴马隆片(Urinorm,规格:50 mg)的生物等效性。
次要目的:观察受试制剂苯溴马隆片与参比制剂苯溴马隆片(Urinorm)在健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the test preparation benzbromarone tablets (specification: 50 mg, manufacturer: Zhejiang Huahai Pharmaceutical Technology Co., Ltd.) and the reference preparation benzbromarone tablets (Urinorm, specification: 50 mg) of which Toaieyo Co., Ltd. is the licensee in healthy male and female subjects under fasting conditions.
Secondary objective: To observe the safety of the test preparation benzbromarone tablets and the reference preparation benzbromarone tablets (Urinorm) in healthy subjects.
/ CompletedNot Applicable 酮咯酸氨丁三醇片(10 mg)在健康受试者中餐后条件下的生物等效性试验
[Translation] Bioequivalence study of ketorolac tromethamine tablets (10 mg) in healthy volunteers under fed conditions
主要目的:在健康男性与女性受试者中于餐后条件下,评价受试制剂酮咯酸氨丁三醇片【规格:10 mg,生产商:浙江华海制药科技有限公司】和Atnahs Pharma Netherlands Bv为持证商的参比制剂酮咯酸氨丁三醇片【Lixidol,规格:10 mg】的生物等效性。
次要目的:观察受试制剂酮咯酸氨丁三醇片与参比制剂酮咯酸氨丁三醇片(Lixidol)在健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the test preparation Ketorolac Tromethamine Tablets [Specification: 10 mg, manufacturer: Zhejiang Huahai Pharmaceutical Technology Co., Ltd.] and the reference preparation Ketorolac Tromethamine Tablets [Lixidol, Specification: 10 mg] of Atnahs Pharma Netherlands Bv as the licensee in healthy male and female subjects under postprandial conditions.
Secondary objective: To observe the safety of the test preparation Ketorolac Tromethamine Tablets and the reference preparation Ketorolac Tromethamine Tablets (Lixidol) in healthy subjects.
/ CompletedNot Applicable 酮咯酸氨丁三醇片(10 mg)在健康受试者中空腹条件下的生物等效性试验
[Translation] Bioequivalence study of ketorolac tromethamine tablets (10 mg) in healthy subjects under fasting conditions
主要目的:在健康男性与女性受试者中于空腹条件下,评价受试制剂酮咯酸氨丁三醇片【规格:10 mg,生产商:浙江华海制药科技有限公司】和Atnahs Pharma Netherlands Bv为持证商的参比制剂酮咯酸氨丁三醇片【Lixidol,规格:10 mg】的生物等效性。
次要目的:观察受试制剂酮咯酸氨丁三醇片与参比制剂酮咯酸氨丁三醇片(Lixidol)在健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the test preparation Ketorolac Tromethamine Tablets [Specification: 10 mg, manufacturer: Zhejiang Huahai Pharmaceutical Technology Co., Ltd.] and the reference preparation Ketorolac Tromethamine Tablets [Lixidol, Specification: 10 mg] of Atnahs Pharma Netherlands Bv as the licensee in healthy male and female subjects under fasting conditions.
Secondary objective: To observe the safety of the test preparation Ketorolac Tromethamine Tablets and the reference preparation Ketorolac Tromethamine Tablets (Lixidol) in healthy subjects.
100 Clinical Results associated with Zhejiang Huahai Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Zhejiang Huahai Pharmaceutical Technology Co., Ltd.
100 Deals associated with Zhejiang Huahai Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Zhejiang Huahai Pharmaceutical Technology Co., Ltd.