[Translation] A randomized, open-label, two-formulation, single-dose, two-sequence, four-period, completely repeated crossover bioequivalence study of pentoxifylline extended-release tablets in healthy subjects under fasting and fed conditions
主要研究目的
研究空腹和餐后状态下单次口服受试制剂己酮可可碱缓释片(规格:0.4g,江苏和晨药业有限公司生产并提供)与参比制剂己酮可可碱缓释片(商品名:Trental®,规格:400 mg,Sanofi-Aventis Deutschland GmbH),在健康成年受试者体内的药代动力学,评价空腹和餐后口服两种制剂的生物等效性。
次要研究目的
评价中国健康受试者空腹和餐后状态下,单次口服受试制剂己酮可可碱缓释片和参比制剂己酮可可碱缓释片(Trental®)后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test pentoxifylline sustained-release tablets (specification: 0.4g, produced and provided by Jiangsu Hechen Pharmaceutical Co., Ltd.) and the reference pentoxifylline sustained-release tablets (trade name: Trental®, specification: 400 mg, Sanofi-Aventis Deutschland GmbH) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after fasting and fed oral administration.
Secondary study objectives
To evaluate the safety of the test pentoxifylline sustained-release tablets and the reference pentoxifylline sustained-release tablets (Trental®) in Chinese healthy subjects after a single oral administration in the fasting and fed state.