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Clinical Trials associated with BCM857BCM857口溶膜与对照药在中国健康志愿者中空腹及餐后状态下的生物等效性试验
[Translation] Bioequivalence study of BCM857 orodispersible film and control drug in Chinese healthy volunteers under fasting and fed conditions
主要目的
观察BCM857口溶膜在中国健康受试者中单次口服给药后活性成分的体内动力学过程,估算相应的药代动力学参数,并以在国内上市的原研药品为对照药,进行生物等效性评价。
次要目的
1.观察BCM857口溶膜受试制剂和已上市对照药在健康人体中的安全性。
2. 比较空腹条件下受试制剂不同给药方式(给水条件和不给水服药)对相对生物利用度的影响;
3. 对受试者服用BCM857口溶膜(受试制剂,不给水服药)和已上市对照药的口感(适口性)进行评价;
4. 考察和记录BCM857口溶膜(受试制剂,不给水服药)在口腔的溶化时间、黏膜粘附性和刺激性。
[Translation] Main purpose
To observe the in vivo kinetics of the active ingredient of BCM857 orodispersible film after a single oral administration in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and evaluate the bioequivalence using the original drug marketed in China as the control drug.
Secondary purpose
1. To observe the safety of the BCM857 orodispersible film test preparation and the marketed control drug in healthy humans.
2. To compare the effects of different administration methods (water and no water) on the relative bioavailability of the test preparation under fasting conditions;
3. To evaluate the taste (palatability) of the BCM857 orodispersible film (test preparation, no water) and the marketed control drug taken by the subjects;
4. To investigate and record the dissolution time, mucosal adhesion and irritation of BCM857 orodispersible film (test preparation, no water) in the oral cavity.
100 Clinical Results associated with BCM857
100 Translational Medicine associated with BCM857
100 Patents (Medical) associated with BCM857
100 Deals associated with BCM857