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.
盐酸米诺环素胶囊(50 mg)在健康受试者中的空腹和餐后生物等效性试验
[Translation] Bioequivalence study of minocycline hydrochloride capsules (50 mg) in healthy subjects after fasting and feeding
主要目的:在健康受试者中,评价Pfizer Japan Inc.持证的参比制剂盐酸米诺环素胶囊(MINOMYCIN,50 mg (按C23H27N3O7计))与浙江华海制药科技有限公司生产的受试制剂盐酸米诺环素胶囊(50 mg(按C23H27N3O7计))在空腹和餐后条件下的生物等效性。
次要目的:观察受试制剂盐酸米诺环素胶囊与参比制剂盐酸米诺环素胶囊(MINOMYCIN)在健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the reference preparation minocycline hydrochloride capsules (MINOMYCIN, 50 mg (calculated as C23H27N3O7)) certified by Pfizer Japan Inc. and the test preparation minocycline hydrochloride capsules (50 mg (calculated as C23H27N3O7)) produced by Zhejiang Huahai Pharmaceutical Technology Co., Ltd. under fasting and fed conditions in healthy subjects.
Secondary objective: To observe the safety of the test preparation minocycline hydrochloride capsules and the reference preparation minocycline hydrochloride capsules (MINOMYCIN) in healthy subjects.
雷米普利片(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 ramipril tablets (5 mg) in healthy volunteers under fasting/fed conditions
主要研究目的:在健康男性与女性受试者中于空腹/餐后条件下,评价受试制剂雷米普利片(规格:5 mg,生产商:浙江华海制药科技有限公司)和Sanofi Belgium为持证商的参比制剂雷米普利片(Tritace,规格:5 mg)的生物等效性。
次要研究目的:观察受试制剂雷米普利片与参比制剂雷米普利片(Tritace)在健康受试者中的安全性。
[Translation] Primary study objective: To evaluate the bioequivalence of the test preparation Ramipril Tablets (Specification: 5 mg, Manufacturer: Zhejiang Huahai Pharmaceutical Technology Co., Ltd.) and the reference preparation Ramipril Tablets (Tritace, Specification: 5 mg) licensed by Sanofi Belgium in healthy male and female subjects under fasting/postprandial conditions.
Secondary study objective: To observe the safety of the test preparation Ramipril Tablets and the reference preparation Ramipril Tablets (Tritace) in healthy subjects.
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