Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

Capital Medical University

Status and phase: Unknown; Phase 1

Conditions: Bacterial Conjunctivitis

Treatments: Drug: azithromycin eye drops by essex; Drug: azithromycin eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT03235141

ESSEX-AOS-PK-2001

Details and patient eligibility

About

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.

Full 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 control drug, elution given to the test drug.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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56 participants in 2 patient groups

azithromycin eye drops by essex

Experimental group

Description:

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.

Treatment:

Drug: azithromycin eye drops by essex

Drug: azithromycin eye drops

AzaSite

Active Comparator group

Description:

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.

Treatment:

Drug: azithromycin eye drops by essex

Drug: azithromycin eye drops