To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.
In this randomized, open, single-center study, 42 healthy volunteers will receive one drop of azithromycin into each eye. Azithromycin tear concentrations will be measured by LC-MS/MS at seven time points for 24 hours. Tolerability is evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Tear samples will be collected using the strips.
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
RECRUITINGthe maximum concentration (Cmax)
The tear samples are taken at 7 time points after administration up to 24 hours.The Cmax is calculated at the average concentration of each point.
Time frame: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
area under the curve (AUC)
The tear samples are taken at 7 time points after administration up to 24 hours.The AUC is calculated at the average concentration of each point.
Time frame: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
AEs
Ocular and systemic adverse events
Time frame: 24 hours
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