/ CompletedNot Applicable 利奥西呱片(2.5 mg)单次给药餐后状态下在健康男性受试者中的生物等效性试验
[Translation] Bioequivalence study of a single dose of riociguat tablets (2.5 mg) in healthy male subjects in the fed state
主要目的:在健康男性受试者中于餐后条件下,评价受试制剂利奥西呱片(规格:2.5 mg,生产商:浙江华海制药科技有限公司)和Bayer AG为持证商的参比制剂利奥西呱片(安吉奥,规格:2.5 mg)的生物等效性。
次要目的:观察受试制剂利奥西呱片与参比制剂利奥西呱片(安吉奥)在健康男性受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the test preparation Riociguat Tablets (Specification: 2.5 mg, Manufacturer: Zhejiang Huahai Pharmaceutical Technology Co., Ltd.) and the reference preparation Riociguat Tablets (Angio, Specification: 2.5 mg) of which Bayer AG is the licensee in healthy male subjects under postprandial conditions.
Secondary objective: To observe the safety of the test preparation Riociguat Tablets and the reference preparation Riociguat Tablets (Angio) in healthy male subjects.
/ CompletedNot Applicable 苯溴马隆片(50 mg)空腹/餐后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 volunteers under fasting and fed conditions
主要目的:在健康男性与女性受试者中于空腹/餐后条件下,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/postprandial 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 磷酸奥司他韦干糖浆【3%(30 g)】单次给药空腹和餐后状态下在健康受试者中的生物等效性试验
[Translation] Bioequivalence study of single-dose oseltamivir phosphate dry syrup [3% (30 g)] in healthy volunteers under fasting and fed conditions
主要目的:
在健康男性与女性受试者中于空腹和餐后条件下,评价受试制剂磷酸奥司他韦干糖浆【规格:3%(30 g)】,生产商:浙江华海制药科技有限公司)和中外製薬株式会社生产的参比制剂磷酸奥司他韦干糖浆【TAMIFLU,规格:3%(30 g)】的生物等效性。
次要目的:
观察受试制剂磷酸奥司他韦干糖浆与参比制剂磷酸奥司他韦干糖浆(TAMIFLU)在健康受试者中的安全性。
[Translation] Main purpose:
The test preparation oseltamivir phosphate dry syrup [specification: 3% (30 g)], manufacturer: Zhejiang Huahai Pharmaceutical Technology Co., Ltd.) and Bioequivalence of the reference preparation oseltamivir phosphate dry syrup [TAMIFLU, specification: 3% (30 g)] produced by Chugai Seiki Co., Ltd.
Secondary purpose:
To observe the safety of the test preparation oseltamivir phosphate dry syrup and the reference preparation oseltamivir phosphate dry syrup (TAMIFLU) 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.