Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

NCT03235141 | Unknown Phase 1 FDA Drug

• 1 other identifier: ESSEX-AOS-PK-2001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Conjunctivitis

Keywords

Azithromycin eye drops; Local Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• AE

  from the ICF signed to the end of the trial,through study completion, an average of 1 year

• SAE

  from the ICF signed to the end of the trial,through study completion, an average of 1 year

Study Arms (2)

azithromycin eye drops by essex

EXPERIMENTAL

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; Drug: azithromycin eye drops

AzaSite

ACTIVE COMPARATOR

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; Drug: azithromycin eye drops

Interventions

azithromycin eye drops by essex DRUG

azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),

AzaSite; azithromycin eye drops by essex

azithromycin eye drops DRUG

azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc

Also known as: AzaSite

AzaSite; azithromycin eye drops by essex

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• Zhuhai Essex Bio-Pharmaceutical Company Limited: collaborator
• Panacea Technologies: collaborator

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Xiuli Zhao

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zhao, Doctor

CONTACT

+86-13911901818; XL_Zhao_YLJD@163.com

Siyang Ni, Doctor

CONTACT

+86-18911810275; grandnsy@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Phase I Clinical Trial Center

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: August 1, 2017
• Study Start: July 7, 2017
• Primary Completion: October 30, 2017
• Study Completion: December 30, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)