[Translation] A single-center, randomized, open-label, single-dose, two-sequence, four-cycle, fully replicated crossover bioequivalence trial of levalbuterol tartrate inhalation aerosol in Chinese healthy subjects under fasting conditions
主要研究目的:研究健康受试者空腹经口吸入受试制剂酒石酸左沙丁胺醇吸入气雾剂(0.045 mg/INH*2次)和参比制剂“Xopenex Hfa®”(0.045 mg/INH*2次)的药代动力学,评价空腹经口吸入酒石酸左沙丁胺醇吸入气雾剂的生物等效性。
次要研究目的:研究受试制剂酒石酸左沙丁胺醇吸入气雾剂和参比制剂“Xopenex Hfa®”在健康受试者中的安全性。
[Translation] Main research purpose: To study the oral inhalation of the test preparation levalbuterol tartrate inhalation aerosol (0.045 mg/INH*2 times) and the reference preparation "Xopenex Hfa®" (0.045 mg/INH*2 times) in healthy subjects on an empty stomach. Pharmacokinetics, to evaluate the bioequivalence of fasting oral inhalation aerosol of levalbuterol tartrate.
Secondary study purpose: To study the safety of the test formulation Levalbuterol Tartrate Inhalation Aerosol and the reference formulation "Xopenex Hfa®" in healthy subjects.