[Translation] Single-centre, randomized, open-label, two-period, two-sequence, crossover, single-dose design in healthy adult subjects to evaluate bioequivalence studies in the fasted/fed state.
主要目的:本研究以厦门恩成制药有限公司研发的甲磺酸倍他司汀片(规格:6 mg)为受试制剂,按生物等效性研究的有关规定,以原研地产化药品厂家卫材(中国)药业有限公司生产的甲磺酸倍他司汀片(商品名:敏使朗®,规格:6 mg)为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。
次要目的:观察受试制剂甲磺酸倍他司汀片和参比制剂甲磺酸倍他司汀片(商品名:敏使朗®)在健康受试者中的安全性。
[Translation] Main purpose: In this study, betahistine mesylate tablets (specification: 6 mg) developed by Xiamen Encheng Pharmaceutical Co., Ltd. Betahistine mesylate tablets (trade name: Minshilang®, specification: 6 mg) produced by China Material (China) Pharmaceutical Co., Ltd. was used as the reference preparation, and the test preparation and the reference preparation were evaluated on an empty stomach/after meal. Bioequivalence after administration under conditions.
Secondary purpose: To observe the safety of the test preparation Betahistine Mesylate Tablets and the reference preparation Betahistine Mesylate Tablets (trade name: Minshilang®) in healthy subjects.