[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of eperisone hydrochloride tablets (50 mg) in Chinese healthy subjects under fasting and postprandial administration conditions
主要研究目的:按有关生物等效性试验的规定,选择卫材(中国)药业有限公司持证的盐酸乙哌立松片(商品名:妙纳,规格:50mg)为参比制剂,对成都硕德药业有限公司生产并提供的受试制剂盐酸乙哌立松片(规格:50mg)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,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康受试者口服受试制剂盐酸乙哌立松片(规格:50mg)和参比制剂盐酸乙哌立松片(商品名:妙纳,规格:50mg)的安全性。
[Translation] Main study purpose: According to the relevant provisions of bioequivalence test, the certified Eperisone Hydrochloride Tablets (trade name: Miaona, specification: 50mg) of Eisai (China) Pharmaceutical Co., Ltd. were selected as the reference preparation, and the test preparation Eperisone Hydrochloride Tablets (specification: 50mg) produced and provided by Chengdu Shuode Pharmaceutical Co., Ltd. were subjected to human bioequivalence test on fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary study purpose: To observe the safety of oral administration of the test preparation Eperisone Hydrochloride Tablets (specification: 50mg) and the reference preparation Eperisone Hydrochloride Tablets (trade name: Miaona, specification: 50mg) to healthy subjects.