Ethic
The bioequivalence study has been registered on ClinicalTrials.gov
(No.:NCT04885660, retrospectively registered in May 2021) and been
approved bythe Medical Ethics Committeeof the Affiliated Hospital of
Qingdao University (No.: QYFYEC 2018–055-01). The study was conducted
in accordance with the Declaration of Helsinki, Good Clinical Practice
(GCP) and applicable lawsand regulationsof China National Medical
Products Administration(NMPA).Writteninformed consent wasobtained from
all subjects before their participation in the study.