[Translation] A randomized, open-label, two-dose, four-period, completely repeated crossover bioequivalence study of theophylline sustained-release tablets in healthy subjects under fasting and fed conditions
主要研究目的:本研究考察健康受试者在空腹及餐后条件下,单次口服由湖南绅泰春制药股份有限公司提供的茶碱缓释片(受试制剂,规格:100mg)与相同条件下单次口服由日医工株式会社持证的茶碱缓释片(参比制剂R,商品名:UNICONTM,规格:100mg)的药动学特征,评价两制剂间的生物等效性,为受试制剂的一致性评价提供依据。
次要研究目的:观察健康受试者在空腹及餐后条件下单次口服100mg的受试制剂茶碱缓释片(规格:100mg)与参比制剂茶碱缓释片(商品名:UNICONTM,规格:100mg)的安全性
[Translation] Main research purpose: This study investigates the pharmacokinetic characteristics of theophylline sustained-release tablets (test preparation, specification: 100 mg) provided by Hunan Shentaichun Pharmaceutical Co., Ltd. and theophylline sustained-release tablets (reference preparation R, trade name: UNICONTM, specification: 100 mg) certified by Nichiyo Co., Ltd. under the same conditions when taken orally once in a single dose in healthy subjects under fasting and postprandial conditions, evaluates the bioequivalence between the two preparations, and provides a basis for the consistency evaluation of the test preparation.
Secondary research purpose: Observe the safety of the test preparation theophylline sustained-release tablets (specification: 100 mg) and the reference preparation theophylline sustained-release tablets (trade name: UNICONTM, specification: 100 mg) taken orally once in a single dose in healthy subjects under fasting and postprandial conditions