[Translation] A single-center, randomized, open-label, two-period, two-sequence, crossover, single-dose study was conducted in healthy adult subjects to evaluate the bioequivalence under fasting/fed conditions.
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] Primary objective: This study used betahistine mesylate tablets (specification: 6 mg) developed by Xiamen Encheng Pharmaceutical Co., Ltd. as the test preparation. According to the relevant provisions of bioequivalence studies, betahistine mesylate tablets (trade name: Minshilang®, specification: 6 mg) produced by Eisai (China) Pharmaceutical Co., Ltd., an original localized drug manufacturer, were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.
Secondary objective: To observe the safety of the test preparation betahistine mesylate tablets and the reference preparation betahistine mesylate tablets (trade name: Minshilang®) in healthy subjects.