Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
The test group was completed in sequence from low to high concentrations, and safety tolerance was assessed after administration in one concentration group to determine whether to conduct follow-up group studies and, if necessary, adjust sampling time points according to pre-experimental results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Pazufloxacin Mesilate ear drops of 0.1%,0.3%,0.5%
Jiangsu Province People's Hospital
Nanjing, Jiangsu, China
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v4.0
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
Time frame: Within two days after administration
Cmax
Pharmacokinetics
Time frame: Within two days after administration
Tmax
Pharmacokinetics
Time frame: Within two days after administration
Area under concentration time curve
Pharmacokinetics
Time frame: Within two days after administration
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