NCT03252067

Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

Tear Concentrations and Pharmacokinetics of Azithromycin Following Topical Administration of a Single Dose of Azithromycin Eyedrops in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 points for 24 hours. Tolerability is evaluated.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	azithromycin eyedrop	Tear samples will be collected using the strips.

Timeline

• Start date: 2017-08-02
• Primary completion: 2017-10-31
• Completion: 2017-12-31
• First posted: 2017-08-17
• Last updated: 2017-08-17

Locations

1 site across 1 country: China