Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- AUC0-t
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
azithromycin eye drops by essex
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.
Intervention: azithromycin eye drops (Drug)
azithromycin eye drops by essex
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.
Intervention: azithromycin eye drops by essex (Drug)
AzaSite
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.
Intervention: azithromycin eye drops by essex (Drug)
AzaSite
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.
Intervention: azithromycin eye drops (Drug)
Outcomes
Primary Outcomes
AUC0-t
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
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
Secondary Outcomes
- 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)
- AE(from the ICF signed to the end of the trial,through study completion, an average of 1 year)
- SAE(from the ICF signed to the end of the trial,through study completion, an average of 1 year)
Investigators
Xiuli Zhao
Director of Phase I Clinical Trial Center
Beijing Tongren Hospital