Status:
UNKNOWN
Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
Lead Sponsor:
Beijing Tongren Hospital
Collaborating Sponsors:
Grand Pharmaceutical (China) Co., Ltd.
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 po...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2017
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03252067
Start Date
August 2 2017
End Date
December 31 2017
Last Update
August 17 2017
Active Locations (1)
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1
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730