[Translation] A randomized, open-label, two-sequence, two-formulation, four-period, completely repeated crossover bioequivalence study of a single oral dose of tizanidine hydrochloride tablets in healthy volunteers
主要研究目的:
试验餐后状态下单次口服受试制剂盐酸替扎尼定片(规格:2 mg,江苏和晨药业有限公司生产)与参比制剂盐酸替扎尼定片(商品名:Sirdalud,规格:2 mg,Novartis Farma S.p.A.生产)在健康成年受试者体内的药代动力学特征,评价餐后状态口服两种制剂的生物等效性。
次要研究目的:
餐后状态下,评估单次口服盐酸替扎尼定片受试制剂和参比制剂(商品名:Sirdalud)在健康成年受试者中的安全性。
[Translation] Main study objectives:
To investigate the pharmacokinetic characteristics of the test preparation of tizanidine hydrochloride tablets (specification: 2 mg, produced by Jiangsu Hechen Pharmaceutical Co., Ltd.) and the reference preparation of tizanidine hydrochloride tablets (trade name: Sirdalud, specification: 2 mg, produced by Novartis Farma S.p.A.) in healthy adult subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state.
Secondary study objectives:
To evaluate the safety of the test preparation of tizanidine hydrochloride tablets and the reference preparation (trade name: Sirdalud) in healthy adult subjects after a single oral administration in the fed state.