Tianjin Kanghong Pharmaceutical Science & Technology Development Co Ltd

To evaluate the efficacy and safety of inhaled ambroxol hydrochloride solution in improving the sputum symptoms of lower respiratory tract infection in adults, using placebo (normal saline) as a control.

The pharmacokinetic parameters were used as the primary endpoints to compare the pharmacokinetic behaviors of the test preparation sodium leucovorin injection (T, specification 1ml: 50mg, produced by Tianjin Biochemical Pharmaceutical Co., Ltd.) and the reference preparation calcium leucovorin injection (R, specification 25mg, produced by Qilu Pharmaceutical Co., Ltd.) in healthy subjects after intravenous infusion, and to evaluate the bioequivalence and safety of the two preparations in healthy subjects.

The pharmacokinetic parameters were used as the primary endpoints to compare the bioequivalence of the test preparation and the reference preparation in humans after fasting and postprandial administration.