[Translation] Single-center, open-label, randomized, single-dose evaluation of the test formulation pentoxifylline extended-release tablets (strength: 400mg) and the reference formulation (Trental®, strength: 400mg) in healthy adult subjects under fasting and fed conditions , two-period, two-sequence, 2×2 crossover bioequivalence study
考察健康受试者在空腹及餐后条件下,单次口服由江苏慧聚药业股份有限公司提供的己酮可可碱缓释片(受试制剂,规格:400 mg)或由Sanofi持证的己酮可可碱缓释片(参比制剂,商品名:Trental®,规格:400 mg)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] Investigate healthy subjects under fasting and postprandial conditions, a single oral administration of pentoxifylline sustained-release tablets (test preparation, specification: 400 mg) provided by Jiangsu Huiju Pharmaceutical Co., Ltd. or Sanofi certified Pharmacokinetic characteristics of pentoxifylline sustained-release tablets (reference preparation, trade name: Trental®, strength: 400 mg), evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation .