己酮可可碱缓释片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of pentoxifylline sustained-release tablets in humans under fasting and fed conditions
考察健康受试者在空腹及餐后条件下,单次口服由河北一品生物医药有限公司提供的己酮可可碱缓释片(受试制剂,规格:0.4 g)或由 Sanofi 持证的己酮可可碱缓释片(参比制剂,商品名:Trental®,规格:400mg)的药动学特征,评价两制剂的生物等效性及安全性,为该受试制剂注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single oral administration of pentoxifylline sustained-release tablets (test preparation, specification: 0.4 g) provided by Hebei Yipin Biopharmaceutical Co., Ltd. or pentoxifylline sustained-release tablets (reference preparation, trade name: Trental®, specification: 400 mg) certified by Sanofi to healthy subjects under fasting and postprandial conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.
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