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Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

Primary Purpose

Bacterial Conjunctivitis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
azithromycin eye drops by essex
azithromycin eye drops
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Conjunctivitis focused on measuring Azithromycin eye drops, Local Pharmacokinetics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Beijing Tongren HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

azithromycin eye drops by essex

AzaSite

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

AUC0-t
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

Secondary Outcome Measures

Cmax
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
AE
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.
SAE
Any serious adverse events that occur during the clinical study, whether or not related to the drug should be collected.

Full Information

First Posted
July 5, 2017
Last Updated
July 27, 2017
Sponsor
Beijing Tongren Hospital
Collaborators
Zhuhai Essex Bio-Pharmaceutical Company Limited, Panacea Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT03235141
Brief Title
Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
Official Title
Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Anticipated)
Study Completion Date
December 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital
Collaborators
Zhuhai Essex Bio-Pharmaceutical Company Limited, Panacea Technologies

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis
Keywords
Azithromycin eye drops, Local Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
There are 8 subjects will be enrolled in pre-test, each subject was sampled in two eyes and each subject participated in two cycles of the trial. 8 subjects, 16 eyes participated in the study, 32 samples of tears total . There are 48 subjects 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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
azithromycin eye drops by essex
Arm Type
Experimental
Arm Description
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.
Arm Title
AzaSite
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
azithromycin eye drops by essex
Intervention Description
azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),
Intervention Type
Drug
Intervention Name(s)
azithromycin eye drops
Other Intervention Name(s)
AzaSite
Intervention Description
azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc
Primary Outcome Measure Information:
Title
AUC0-t
Description
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
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
Secondary Outcome Measure Information:
Title
Cmax
Description
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
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
Title
AE
Description
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.
Time Frame
from the ICF signed to the end of the trial,through study completion, an average of 1 year
Title
SAE
Description
Any serious adverse events that occur during the clinical study, whether or not related to the drug should be collected.
Time Frame
from the ICF signed to the end of the trial,through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuli Zhao, Doctor
Phone
+86-13911901818
Email
XL_Zhao_YLJD@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Siyang Ni, Doctor
Phone
+86-18911810275
Email
grandnsy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Zhao
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Wu
Phone
010-58268422
Email
trdrug@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

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