[Translation] Randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial of betahistine hydrochloride tablets (8 mg) in Chinese healthy subjects under fasting and postprandial administration conditions
按有关生物等效性试验的规定,选择Mylan Medical SAS为持证商为生产商的盐酸倍他司汀片(商品名:SERC,规格:8mg)为参比制剂,对上海理想制药有限公司提供的受试制剂盐酸倍他司汀片(规格:8mg)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评估两种制剂在空腹和餐后给药条件下的生物等效性。观察健康志愿受试者口服受试制剂盐酸倍他司汀片(规格:8mg)和参比制剂盐酸倍他司汀片(商品名:SERC,规格:8mg)的安全性。
[Translation] According to the relevant regulations on bioequivalence testing, betahistine hydrochloride tablets (trade name: SERC, specification: 8 mg), which is produced by Mylan Medical SAS as a license holder and manufacturer, was selected as the reference preparation and was provided to Shanghai Ideal Pharmaceutical Co., Ltd. The test preparation betahistine hydrochloride tablets (specification: 8 mg) were administered to human subjects on an empty stomach and after meals for bioequivalence testing to compare whether the absorption speed and extent of the drug in the test preparation were significantly different from those of the reference preparation. Within the accepted range, the two formulations were evaluated for bioequivalence under fasting and postprandial dosing conditions. Observe the safety of the test preparation betahistine hydrochloride tablets (specification: 8mg) and the reference preparation betahistine hydrochloride tablets (trade name: SERC, specification: 8mg) orally administered to healthy volunteer subjects.