/ Active, not recruitingNot 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.
/ RecruitingNot Applicable 利奥西呱片(2.5 mg)单次给药空腹/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 under fasting/fed conditions
主要目的:在健康男性受试者中于空腹/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 fasting/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 磷酸芦可替尼片(5 mg)随机、开放、两周期、两交叉单次给药空腹/餐后状态下在健康受试者中的生物等效性试验
[Translation] A randomized, open-label, two-period, two-crossover single-dose bioequivalence study of ruxolitinib phosphate tablets (5 mg) in healthy subjects under fasting/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,评价受试制剂磷酸芦可替尼片(规格:5 mg,生产商:浙江华海制药科技有限公司)和Novartis Pharma Schweiz AG为持证商的参比制剂磷酸芦可替尼片(捷恪卫,Jakavi,规格:5 mg)的生物等效性。
次要目的:
观察受试制剂磷酸芦可替尼片与参比制剂磷酸芦可替尼片(捷恪卫,Jakavi)在健康受试者中的安全性。
[Translation] Primary objective:
To evaluate the bioequivalence of the test preparation ruxolitinib phosphate tablets (specification: 5 mg, manufacturer: Zhejiang Huahai Pharmaceutical Technology Co., Ltd.) and the reference preparation ruxolitinib phosphate tablets (Jakavi, specification: 5 mg) licensed by Novartis Pharma Schweiz AG in healthy male and female subjects under fasting/postprandial conditions.
Secondary objective:
To observe the safety of the test preparation ruxolitinib phosphate tablets and the reference preparation ruxolitinib phosphate tablets (Jakavi) in healthy subjects.
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