Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03252067
• Other study ID #: TR-PK-201402
• Status: Recruiting
• Phase: Phase 1
• First received: August 4, 2017
• Last updated: August 14, 2017
• Start date: August 2, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2017
• Source: Beijing Tongren Hospital
• Contact: Feng Wu, Master
• Phone: 010-58268486
• Email: trdrug[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• azithromycin eyedrop
Tear samples will be collected using the strips.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tongren Hospital	Grand Pharma (China) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the maximum concentration (Cmax)	The tear samples are taken at 7 time points after administration up to 24 hours.The Cmax is calculated at the average concentration of each point.	The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
Primary	area under the curve (AUC)	The tear samples are taken at 7 time points after administration up to 24 hours.The AUC is calculated at the average concentration of each point.	The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
Secondary	AEs	Ocular and systemic adverse events	24 hours