NCT03235141

Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 control drug, elution given to the test drug.

Conditions

• Bacterial Conjunctivitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-07-07
• Primary completion: 2017-10-30
• Completion: 2017-12-30
• First posted: 2017-08-01
• Last updated: 2017-08-01

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study