[Translation] A single-center, randomized, open-label, single-dose (fasting) oral administration, two-formulation, two-sequence, two-period, crossover human bioequivalence trial of levocarnitine tablets in healthy Chinese subjects.
主要目的:观察中国健康受试者在空腹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,初步评价空腹状态下两种制剂在健康受试者体内的生物等效性。
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 formulation levocarnitine tablets (330 mg; manufactured by Liaoning Novino Pharmaceutical Co., Ltd.) and the reference formulation levocarnitine tablets (trade name: CARNITOR®; 330 mg; licensee: Leadiant Biosciences Inc.) after a single oral administration in healthy Chinese subjects under fasting conditions, and to preliminarily evaluate the bioequivalence of the two formulations in healthy subjects under fasting conditions.
Secondary objective: To observe the safety of the test formulation levocarnitine tablets and the reference formulation levocarnitine tablets (CARNITOR®) in healthy Chinese subjects.