Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
- Registration Number
- NCT03252067
- Lead Sponsor
- Beijing Tongren Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description azithromycin eyedrop azithromycin eyedrop 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.
- Primary Outcome Measures
Name Time Method the maximum concentration (Cmax) 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. 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.
area under the curve (AUC) 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. 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.
- Secondary Outcome Measures
Name Time Method AEs 24 hours Ocular and systemic adverse events
Trial Locations
- Locations (1)
Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China