[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period, fully repeated crossover bioequivalence study of pentoxifylline sustained-release tablets in healthy subjects under fasting/postprandial administration conditions
主要目的:考察中国健康受试者在空腹/餐后条件下单次口服浙江众延医药科技有限公司的己酮可可碱缓释片与持证商 Neuraxpharm Arzneimittel GmbH的己酮可可碱缓释片后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:评价单剂量口服己酮可可碱缓释片受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of pentoxifylline sustained-release tablets of Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd. and pentoxifylline sustained-release tablets of Neuraxpharm Arzneimittel GmbH in healthy Chinese subjects after a single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test and reference preparations of pentoxifylline sustained-release tablets in healthy Chinese subjects after a single oral administration.