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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03235141
Other study ID # ESSEX-AOS-PK-2001
Secondary ID
Status Recruiting
Phase Phase 1
First received July 5, 2017
Last updated July 27, 2017
Start date July 7, 2017
Est. completion date December 30, 2017

Study information

Verified date July 2017
Source Beijing Tongren Hospital
Contact Xiuli Zhao, Doctor
Phone +86-13911901818
Email XL_Zhao_YLJD@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date December 30, 2017
Est. primary completion date October 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Drug:
azithromycin eye drops by essex
azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),
azithromycin eye drops
azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc

Locations

Country Name City State
China Beijing Tongren Hospital Beijing Beijing

Sponsors (3)

Lead Sponsor Collaborator
Beijing Tongren Hospital Panacea Technology Co.,Ltd, Zhuhai Essex Bio-Pharmaceutical Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 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 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 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. from the ICF signed to the end of the trial,through study completion, an average of 1 year
Secondary SAE 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
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