[Translation] Randomized, open-label, single-dose, two-dose, two-sequence, four-period, fully repeated cross-over bioequivalence study of aminophylline tablets (0.1g) in Chinese healthy subjects under fasting and postprandial administration conditions
主要研究目的:按有关生物等效性试验的规定,选择Sannova Co., Ltd.为持证商的氨茶碱片(商品名:Neophyllin®,规格:0.1g)为参比制剂,对山西太原药业有限公司生产的受试制剂氨茶碱片(规格:0.1g)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,比较两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂氨茶碱片(规格:0.1g)和参比制剂氨茶碱片(商品名:Neophyllin®,规格:0.1g)的安全性。
[Translation] The main purpose of the study: According to the relevant bioequivalence test regulations, choose aminophylline tablets (trade name: Neophyllin®, specification: 0.1g) with Sannova Co., Ltd. The test preparation aminophylline tablets (specification: 0.1g) produced by Pharmaceutical Co., Ltd. was administered to humans on an empty stomach and after meals for bioequivalence tests, and the absorption speed and degree of drug absorption in the test preparation were compared with those of the reference preparation. Whether the difference is within the acceptable range, compare the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the safety of the test preparation aminophylline tablets (specification: 0.1g) and the reference preparation aminophylline tablets (trade name: Neophyllin®, specification: 0.1g) orally by healthy volunteers.