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评估他达拉非口溶膜作用于健康成年受试者在空腹状态下的生物等效性研究
[Translation] A bioequivalence study evaluating the effects of tadalafil orally dissolved film in healthy adult subjects under fasting conditions
主要目的:研究空腹条件下单剂量口服上海欣峰制药有限公司提供的他达拉非口溶膜(10mg/片)的药代动力学特征,并以Lilly del Caribe,Inc.生产的他达拉非片(10mg/片,商品名:希爱力)作为参比制剂,评价两制剂的人体生物等效性。
次要目的:观察健康受试者单次口服10mg受试制剂他达拉非口溶膜和参比制剂希爱力的安全性。
[Translation] Main purpose: To study the pharmacokinetic characteristics of tadalafil orally dissolving film (10mg/tablet) provided by Shanghai Xinfeng Pharmaceutical Co., Ltd. in a single dose under fasting conditions, and tadalafil produced by Lilly del Caribe, Inc. Non-tablet (10mg/tablet, trade name: Cialis) was used as a reference preparation to evaluate the human bioequivalence of the two preparations.
Secondary purpose: To observe the safety of a single oral administration of 10 mg of the test preparation Tadalafil orally dissolved film and the reference preparation Cialis in healthy subjects.
他达拉非口溶膜作用于健康成年受试者在餐后状态下的生物等效性研究
[Translation] Bioequivalence study of tadalafil orally dissolving film on healthy adult subjects in fed state
主要目的:研究餐后条件下单剂量口服上海欣峰制药有限公司提供的他达拉非口溶膜(10mg/片)的药代动力学特征,并以Lilly del Caribe,Inc.生产的他达拉非片(10mg/片,商品名:希爱力)作为参比制剂,评价两制剂的人体生物等效性。
次要目的:观察健康受试者单次口服10mg受试制剂他达拉非口溶膜和参比制剂希爱力的安全性。
[Translation] Main purpose: To study the pharmacokinetic characteristics of tadalafil orally dissolved film (10mg/tablet) provided by Shanghai Xinfeng Pharmaceutical Co., Ltd. under single-dose oral administration under postprandial conditions, and tadalafil produced by Lilly del Caribe, Inc. Lafei tablets (10mg/tablet, trade name: Cialis) were used as a reference preparation to evaluate the human bioequivalence of the two preparations.
Secondary purpose: To observe the safety of a single oral administration of 10 mg of the test preparation Tadalafil orally dissolved film and the reference preparation Cialis in healthy subjects.
[Translation] Study on the human bioequivalence of ondansetron orally dissolvable film
主要目的:
采用单中心、随机、开放、两周期交叉、单次口服试验设计,比较空腹和餐后给药条件下上海欣峰制药有限公司提供的昂丹司琼口溶膜(规格:8 mg)与Norgine Pharmaceuticals Limited持证的昂丹司琼口溶膜(规格:8 mg)在中国健康人群吸收程度和吸收速度的差异。
次要目的:
评价空腹及餐后条件下,上海欣峰制药有限公司提供的昂丹司琼口溶膜(规格:8 mg)与Norgine Pharmaceuticals Limited持证的昂丹司琼口溶膜(规格:8 mg)的安全性及耐受性。
[Translation] main purpose:
A single-center, randomized, open, two-cycle crossover, single oral trial design was used to compare ondansetron orally dissolvable film (specification: 8 mg) provided by Shanghai Xinfeng Pharmaceutical Co., Ltd. with Norgine under fasting and postprandial administration conditions. Differences in the degree and speed of absorption of ondansetron orally dissolvable film (specification: 8 mg) licensed by Pharmaceuticals Limited among healthy people in China.
Secondary purpose:
To evaluate the performance of ondansetron orally dissolving film (specification: 8 mg) provided by Shanghai Xinfeng Pharmaceutical Co., Ltd. and ondansetron orally dissolving film (specification: 8 mg) licensed by Norgine Pharmaceuticals Limited under fasting and postprandial conditions. Safety and tolerability.
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