[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test formulation, Ondansetron Hydrochloride Tablets (strength: 8 mg), and the reference formulation, Zofran® (strength: 8 mg), in healthy adult participants in the fasting and fed states.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂盐酸昂丹司琼片(规格:8 mg,辰欣药业股份有限公司生产)与参比制剂盐酸昂丹司琼片(Zofran®,规格:8 mg,Novartis Pharma GmbH生产)在健康参与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:评估受试制剂盐酸昂丹司琼片(规格:8 mg)和参比制剂盐酸昂丹司琼片(Zofran®,规格:8 mg)在健康参与者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation ondansetron hydrochloride tablets (specification: 8 mg, produced by Chenxin Pharmaceutical Co., Ltd.) and the reference preparation ondansetron hydrochloride tablets (Zofran®, specification: 8 mg, produced by Novartis Pharma GmbH) in healthy participants 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.
Secondary purpose of the study is to evaluate the safety of the test preparation ondansetron hydrochloride tablets (specification: 8 mg) and the reference preparation ondansetron hydrochloride tablets (Zofran®, specification: 8 mg) in healthy participants.