Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

Conditions
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Bacterial Conjunctivitis

Intervention / Treatment
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* Drug: azithromycin eye drops by essex
* Drug: azithromycin eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 65 years old, male or female; BMI in the range of 19 to 28; eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and fundus examination were normal, tear secretion function is normal; Good compliance and voluntarily signed consent. Exclusion Criteria: Have eye disease or systemic disease; physical examination, laboratory tests, ECG and chest X-ray examination abnormalities and has clinical significance; HBsAg, anti-HCV and HIV positive; those who used eye drops two weeks before the test and who used any dosage form of azithromycin; known to azithromycin or macrolide-related varieties of allergies or serious adverse reactions; need to wear contact lenses during the test; history of internal surgery or laser surgery history; participated in other drug clinical trials in the past three months; pregnant women and lactating women, or in the growth period without taking effective contraceptive measures, menstrual period women; mental illness or alcohol, history of drug abuse or inability to collaborate; Any other circumstances that the investigators consider are unfit to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: There are 8 subjects will be enrolled in pre-test, each subject was sampled in two eyes and each subject participated in two cycles of the trial. 8 subjects, 16 eyes participated in the study, 32 samples of tears total . There are 48 subjects 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: azithromycin eye drops by essex<br>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<br>* azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),<br>Drug: azithromycin eye drops<br>* azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc<br>* Other names: AzaSite;|
| Active Comparator: AzaSite<br>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<br>* azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),<br>Drug: azithromycin eye drops<br>* azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc<br>* Other names: AzaSite;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | from the ICF signed to the end of the trial,through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Azithromycin eye drops, Local Pharmacokinetics