Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

• Status: Unknown status
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beijing Tongren Hospital
• Collaborators: Grand Pharma (China) Co., Ltd; Grand Pharmaceutical (China) Co., Ltd.
• Treatments: Azithromycin; Ophthalmic Solutions; Tetrahydrozoline

Criteria

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.