Status:
UNKNOWN
Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
Lead Sponsor:
Beijing Tongren Hospital
Collaborating Sponsors:
Zhuhai Essex Bio-Pharmaceutical Company Limited
Panacea Technologies
Conditions:
Bacterial Conjunctivitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 cont...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2017
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03235141
Start Date
July 7 2017
End Date
December 30 2017
Last Update
August 1 2017
Active Locations (1)
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1
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100005