[Translation] Single center, randomized, open, single (fasting/after meal) oral administration, two preparations, two sequences, two cycles, crossover human bioequivalence prediction of levocarnitine tablets in Chinese healthy subjects test
"主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂左卡尼汀片(规格:330mg;生产企业:辽宁诺维诺制药股份有限公司)和参比制剂左卡尼汀片(商品名:CARNITOR®;规格330mg;持证商:Leadiant Biosciences Inc)后的药代动力学特征,初步评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂左卡尼汀片和参比制剂左卡尼汀片(CARNITOR®)在中国健康受试者中的安全性。"
[Translation] "Main purpose: To observe Chinese healthy subjects taking a single oral administration of the test preparation levocarnitine tablet (specification: 330mg; manufacturer: Liaoning Novino Pharmaceutical Co., Ltd.) and the reference preparation levocarnitine The pharmacokinetic characteristics of carnitine tablets (trade name: CARNITOR®; specification 330mg; licensee: Leadiant Biosciences Inc) after preliminarily evaluating the bioequivalence of the two preparations in the fasting/fed state.
Secondary purpose: To observe the safety of the test preparation levocarnitine tablet and the reference preparation levocarnitine tablet (CARNITOR®) in Chinese healthy subjects. "