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

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

Study Overview

• Status: Unknown
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: azithromycin eyedrop

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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Feng Wu, Master; Phone Number: 010-58268486; Email: trdrug@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Beijing Tongren Hospital
      • Contact: Feng Wu; Phone Number: 010-58268486; Email: trdrug@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: azithromycin eyedrop; Each of the subjects' eyes will receive single dose of azithromycin eyedrops and then attribute the time for tear sampling at seven time points up to 24 hours.	Drug: azithromycin eyedrop; Tear samples will be collected using the strips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs	Ocular and systemic adverse events	24 hours

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Collaborators: Grand Pharmaceutical (China) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Anticipated): October 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Azithromycin eyedrops, pharmacokinetics, tears
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Azithromycin
• Other Study ID Numbers: TR-PK-201402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No