Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

NCT03252067 | Unknown Phase 1

• 1 other identifier: TR-PK-201402
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.

Conditions

Pharmacokinetics

Keywords

Azithromycin eyedrops, pharmacokinetics, tears

Outcome Measures

Primary Outcomes (2)

• the maximum concentration (Cmax)

  The tear samples are taken at 7 time points after administration up to 24 hours.The Cmax is calculated at the average concentration of each point.

  The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.

• area under the curve (AUC)

  The tear samples are taken at 7 time points after administration up to 24 hours.The AUC is calculated at the average concentration of each point.

  The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.

Secondary Outcomes (1)

• AEs

  24 hours

Study Arms (1)

azithromycin eyedrop

EXPERIMENTAL

Each of the subjects' eyes will receive single dose of azithromycin eyedrops and then attribute the time for tear sampling at seven time points up to 24 hours.

Drug: azithromycin eyedrop

Interventions

azithromycin eyedrop DRUG

Tear samples will be collected using the strips.

azithromycin eyedrop

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 45 years old, male or female;
• BMI in the range of 19 to 24;
• 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, anti-HIV and TPPA 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
• Grand Pharmaceutical (China) Co., Ltd.: collaborator

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Feng Wu, Master

CONTACT

010-58268486; trdrug@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 17, 2017
• Study Start: August 2, 2017
• Primary Completion: October 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 17, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)