[Translation] A single-center, randomized, open-label, single-dose, fasting oral trial of L-carnitine tablets in healthy Chinese participants: a two-formulation, two-sequence, two-period, crossover human bioequivalence pilot study
主要目的:观察中国健康参与者在空腹状态下单次口服受试制剂左卡尼汀片(规格:0.33 g;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0.33 g;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®)在中国健康参与者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation L-carnitine tablets (specification: 0.33 g; manufacturer: Liaoning Novino Pharmaceutical Co., Ltd.) and the reference preparation L-carnitine tablets (trade name: CARNITOR®; specification 0.33 g; licensee: Leadiant Biosciences Inc) after a single oral administration in the fasting state in healthy Chinese participants, and to preliminarily evaluate the bioequivalence of the two preparations in the fasting state.
Secondary objective: To observe the safety of the test preparation L-carnitine tablets and the reference preparation L-carnitine tablets (CARNITOR®) in healthy Chinese participants.