Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

Bacterial Conjunctivitis Clinical Trial

Official title:

Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235141
• Other study ID #: ESSEX-AOS-PK-2001
• 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
• 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.

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

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