Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.

Detailed Description
-----------------
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.

Official Title
-----------------
Tear Concentrations and Pharmacokinetics of Azithromycin Following Topical Administration of a Single Dose of Azithromycin Eyedrops in Healthy Volunteers

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: azithromycin eyedrop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 45 years old, male or female; BMI in the range of 19 to 24; 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, anti-HIV and TPPA 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
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: azithromycin eyedrop<br>Each of the subjects' eyes will receive single dose of azithromycin eyedrops and then attribute the time for tear sampling at seven time points up to 24 hours. | Drug: azithromycin eyedrop<br>* Tear samples will be collected using the strips.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the 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. | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs | Ocular and systemic adverse events | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Azithromycin eyedrops, pharmacokinetics, tears