Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-07

Study Completion Date

2017-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

NCT03252067

Pharmacokinetics

UNKNOWN PHASE1

Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

NCT00356772

Eye Infections, Bacterial

COMPLETED PHASE1

Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers

NCT00356850

Eye Infections, Bacterial

COMPLETED PHASE1

Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

NCT00357383

Eye Infections, Bacterial

COMPLETED PHASE1

Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

NCT00629941

Blepharitis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Conjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

azithromycin eye drops by essex

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.

Group Type EXPERIMENTAL

azithromycin eye drops by essex

Intervention Type DRUG

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

azithromycin eye drops

Intervention Type DRUG

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

AzaSite

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.

Group Type ACTIVE_COMPARATOR

azithromycin eye drops by essex

Intervention Type DRUG

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

azithromycin eye drops

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

azithromycin eye drops by essex

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

Intervention Type DRUG

azithromycin eye drops

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AzaSite

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes