Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

July 27, 2017 updated by: Xiuli Zhao, Beijing Tongren Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Beijing Tongren Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 65 years old, male or female;
  • BMI in the range of 19 to 28;
  • 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 and HIV 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: azithromycin eye drops by essex
In one cycle, give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the AzaSite eye drops,2.5ml/25mg，1 drop，once.
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
Other Names:
  • AzaSite
Active Comparator: AzaSite
In one cycle, give the AzaSite eye drops,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once.
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
Other Names:
  • AzaSite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-t
Time Frame: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The AUC of the test drug and the control drug was calculated at the average concentration of each point
The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The Cmax of the test drug and the control drug was calculated at the average concentration of each point
The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
AE
Time Frame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
compared the laboratory test values before and after treatment,according to the study drug use, calculate the number of cases, the number of cases and the incidence of adverse reactions.
from the ICF signed to the end of the trial,through study completion, an average of 1 year
SAE
Time Frame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
Any serious adverse events that occur during the clinical study, whether or not related to the drug should be collected.
from the ICF signed to the end of the trial,through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Collaborators

Zhuhai Essex Bio-Pharmaceutical Company Limited
Panacea Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2017

Primary Completion (Anticipated)

October 30, 2017

Study Completion (Anticipated)

December 30, 2017

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

July 27, 2017

First Posted (Actual)

August 1, 2017

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESSEX-AOS-PK-2001

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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