[Translation] A randomized, open-label, two-sequence, two-period, crossover bioequivalence study of atenolol tablets in Chinese healthy volunteers after single oral administration on an empty stomach or after a meal
主要研究目的
本研究考察空腹及餐后条件下单次口服受试制剂阿替洛尔片(规格:50 mg/片,生产单位:浙江亚太药业股份有限公司)与参比制剂阿替洛尔片(商品名:Tenormin®,规格:50 mg/片,生产单位:Norwich Pharmaceuticals,Inc.)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
观察单次口服50 mg的受试制剂阿替洛尔片或参比制剂阿替洛尔片(商品名:Tenormin®,50 mg)在健康受试者中的安全性。
[Translation] Main study objectives
This study investigates the pharmacokinetics of the test preparation atenolol tablets (specification: 50 mg/tablet, manufacturer: Zhejiang Asia Pacific Pharmaceutical Co., Ltd.) and the reference preparation atenolol tablets (trade name: Tenormin®, specification: 50 mg/tablet, manufacturer: Norwich Pharmaceuticals, Inc.) in healthy adult subjects after a single oral administration under fasting and fed conditions, and evaluates the bioequivalence of the two preparations after fasting and fed oral administration.
Secondary study objectives
Observe the safety of a single oral administration of 50 mg of the test preparation atenolol tablets or the reference preparation atenolol tablets (trade name: Tenormin®, 50 mg) in healthy subjects.