A Phase 1 interventional study of azithromycin eye drops by essex and azithromycin eye drops in Bacterial Conjunctivitis, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by Beijing Tongren Hospital · Phase 1, Interventional, and Treatment
To compare the pharmacokinetic behavior of azithromycin eye drops in the tear with the original azithromycin eye drops, and evaluate the release behavior of both in the eye.
There are 48 patients will divided into group A and group B randomly . subjects of Group A will given the first test drug, elution after the control drug; Subjects of Group B will given the first control drug, elution given to the test drug.
Exclusion Criteria:
In one cycle, give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the AzaSite eye drops,2.5ml/25mg，1 drop，once.
Drug: azithromycin eye drops by essex · Drug: azithromycin eye drops
In one cycle, give the AzaSite eye drops,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once.
Drug: azithromycin eye drops by essex · Drug: azithromycin eye drops
azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),
azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc
Also known as: AzaSite
AUC0-t
The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The AUC of the test drug and the control drug was calculated at the average concentration of each point
Time frame: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
Cmax
The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The Cmax of the test drug and the control drug was calculated at the average concentration of each point
Time frame: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
AE
compared the laboratory test values before and after treatment,according to the study drug use, calculate the number of cases, the number of cases and the incidence of adverse reactions.
Time frame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
SAE
Any serious adverse events that occur during the clinical study, whether or not related to the drug should be collected.
Time frame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
Plan to share: No
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Beijing Tongren Hospital