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Clinical Trials associated with BCM-332BCM332缓释片和拉考沙胺片在中国健康人体药代动力学和生物利用度研究
[Translation] Study on the pharmacokinetics and bioavailability of BCM332 sustained-release tablets and lacosamide tablets in healthy Chinese volunteers
预试验:
观察BCM332缓释片在空腹和餐后条件下是否存在缓释效应,初步探索本品空腹和餐后条件下的药代动力学参数,为单次给药采血时间点、清洗期等设计提供依据。
单次给药/多次给药PK研究:
主要目的:观察BCM332缓释片和拉考沙胺片在中国健康人体的药代动力学和生物利用度,同时考察BCM332缓释片和拉考沙胺片的生物等效性。
次要目的:观察BCM332缓释片和拉考沙胺片在中国健康人体的安全性。
[Translation] Preliminary test:
Observe whether BCM332 sustained-release tablets have sustained-release effects under fasting and postprandial conditions, preliminarily explore the pharmacokinetic parameters of this product under fasting and postprandial conditions, and provide a basis for the design of single-dose blood sampling time points, washout periods, etc.
Single-dose/multiple-dose PK study:
Main purpose: To observe the pharmacokinetics and bioavailability of BCM332 sustained-release tablets and lacosamide tablets in healthy Chinese subjects, and to investigate the bioequivalence of BCM332 sustained-release tablets and lacosamide tablets.
Secondary purpose: To observe the safety of BCM332 sustained-release tablets and lacosamide tablets in healthy Chinese subjects.
100 Clinical Results associated with BCM-332
100 Translational Medicine associated with BCM-332
100 Patents (Medical) associated with BCM-332
100 Deals associated with BCM-332