Pharmacokinetics
Conditions
Keywords
Azithromycin eyedrops, pharmacokinetics, tears
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.
Interventions
DRUGazithromycin eyedrop
Tear samples will be collected using the strips.
Sponsors
Grand Pharmaceutical (China) Co., Ltd.
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| AEs | 24 hours | Ocular and systemic adverse events |
Countries
China
Contacts
Primary ContactFeng Wu, Master
Outcome results
None listed