Trial | NCT03235141  Report issue

Official Title

Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    56
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.
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 Started
Jul 07
2017
Primary Completion
Oct 30
2017
Anticipated
Study Completion
Dec 30
2017
Anticipated
Last Update
Aug 01
2017

Drug azithromycin eye drops by essex

azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),

Drug azithromycin eye drops

azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc

  • Other names: AzaSite

azithromycin eye drops by essex Experimental

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.

AzaSite Active Comparator

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.

Criteria 

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.
No Results Posted