[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of single oral administration of benzbromarone tablets on an empty stomach or after a meal in healthy volunteers.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂苯溴马隆片(规格:50mg,漯河市汇创医药有限公司持证)与参比制剂苯溴马隆片(Urinorm®,规格:50mg,トーアエイヨー株式会社持证)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。 次要研究目的:评价健康受试者在空腹和餐后状态下,单次口服苯溴马隆片受试制剂和参比制剂后的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation benzbromarone tablets (specification: 50 mg, licensed by Luohe Huichuang Pharmaceutical Co., Ltd.) and the reference preparation benzbromarone tablets (Urinorm®, specification: 50 mg, licensed by Toeiyo Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. The secondary purpose of the study is to evaluate the safety of the test preparation and reference preparation of benzbromarone tablets in healthy subjects after a single oral administration in the fasting and fed state.