[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the efficacy of dexmethylphenidate hydrochloride tablets in healthy adult subjects under the fasting state
主要研究目的:研究空腹状态下单次口服受试制剂盐酸右哌甲酯片(规格:2.5 mg,河南中帅药业有限公司生产)与参比制剂盐酸右哌甲酯片(Focalin®,规格:2.5 mg,Mikart, LLC生产)在健康成年受试者体内的药代动力学参数,评价空腹状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂盐酸右哌甲酯片(规格:2.5 mg)和参比制剂盐酸右哌甲酯片(Focalin®,规格:2.5 mg)在健康成年受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic parameters of the test preparation dexmethylphenidate hydrochloride tablets (specification: 2.5 mg, produced by Henan Zhongshuai Pharmaceutical Co., Ltd.) and the reference preparation dexmethylphenidate hydrochloride tablets (Focalin®, specification: 2.5 mg, produced by Mikart, LLC) in healthy adult subjects after a single oral administration in the fasting state, and to evaluate the bioequivalence of the two preparations in the fasting state.
Secondary purpose of the study: to evaluate the safety of the test preparation dexmethylphenidate hydrochloride tablets (specification: 2.5 mg) and the reference preparation dexmethylphenidate hydrochloride tablets (Focalin®, specification: 2.5 mg) in healthy adult subjects.