To investigate the safety, tolerance, dynamic percolation model of single dose usage pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic suppurative otitis media
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Qingdao Municipal Hospital
Qingdao, China
RECRUITINGsafety and tolerance of pazufloxacin mesilate ear drops
Any changes in vital signs; AE/SAE number
Time frame: 24 hours
PK of pazufloxacin mesilate ear drops
blood samples will be collected at 0, 0.5, and one of the followed time points 2, 4, 6, 8 hours. AUC will be calculated based on the pazufloxacin mesilate concentration at above timepoints in blood.
Time frame: 24 hours
PK of pazufloxacin mesilate ear drops
blood samples will be collected at 0, 0.5, and one of the followed time points 2, 4, 6, 8 hours. Cmax will be calculated based on the pazufloxacin mesilate concentration at above timepoints in blood.
Time frame: 24 hours
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