[Translation] Evaluation of the test preparation Eperisone Hydrochloride Tablets (specification: 50 mg) and the reference preparation Mirena (specification: 50 mg) in a single center, open, randomized, single dose, four cycles in healthy adult subjects under fasting and postprandial conditions , two-sequence, fully replicated crossover bioequivalence study
主要研究目的:研究空腹和餐后状态下单次口服受试制剂盐酸乙哌立松片(规格:50 mg;寿光富康制药有限公司生产)与参比制剂盐酸乙哌立松片(妙纳®,规格:50 mg;卫材(中国)药业有限公司生产)在健康受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂盐酸乙哌立松片(规格:50 mg)和参比制剂盐酸乙哌立松片(妙纳®,规格:50 mg)在健康受试者中的安全性。
[Translation] Main research purpose: To study the single oral administration of the test preparation Eperisone Hydrochloride Tablets (specification: 50 mg; produced by Shouguang Fukang Pharmaceutical Co., Ltd.) and the reference preparation Eperisone Hydrochloride Tablets (Miaona®, specification) in fasting and postprandial states. : 50 mg; produced by Eisai (China) Pharmaceutical Co., Ltd.) in healthy subjects to evaluate the bioequivalence of the two oral formulations in fasting and postprandial states.
Secondary study purpose: To evaluate the safety of the test preparation eperisone hydrochloride tablets (specification: 50 mg) and the reference preparation eperisone hydrochloride tablets (Miona®, specification: 50 mg) in healthy subjects.