[Translation] A single-center, randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of levosalbutamol tartrate inhalation aerosol in Chinese healthy subjects under fasting condition
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] The main purpose of the study is to study the pharmacokinetics of the test preparation salbutamol tartrate inhalation aerosol (0.045 mg/INH*2 times) and the reference preparation "Xopenex Hfa®" (0.045 mg/INH*2 times) in healthy subjects after oral inhalation on an empty stomach, and to evaluate the bioequivalence of the salbutamol tartrate inhalation aerosol after oral inhalation on an empty stomach.
The secondary purpose of the study is to study the safety of the test preparation salbutamol tartrate inhalation aerosol and the reference preparation "Xopenex Hfa®" in healthy subjects.