[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence pilot study of L-carnitine tablets in healthy Chinese subjects: two-formulation, two-sequence, two-period, crossover
"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] "Primary objective: To observe the pharmacokinetic characteristics of the test preparation L-carnitine tablets (specification: 330 mg; manufacturer: Liaoning Novino Pharmaceutical Co., Ltd.) and the reference preparation L-carnitine tablets (trade name: CARNITOR®; specification 330 mg; licensee: Leadiant Biosciences Inc) in Chinese healthy subjects after a single oral administration in the fasting/postprandial state, and to preliminarily evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary objective: To observe the safety of the test preparation L-carnitine tablets and the reference preparation L-carnitine tablets (CARNITOR®) in Chinese healthy subjects."