Clinical trial NCT03235141: Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
Official title: Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bacterial Conjunctivitis
Keywords: Azithromycin eye drops
Local Pharmacokinetics
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Zhuhai Essex Bio-Pharmaceutical Company Limited
name: Panacea Technologies
First posted: 2017-08-01
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: AUC0-t
timeFrame: 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:
measure: Cmax
timeFrame: 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
measure: AE
timeFrame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
measure: SAE
timeFrame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Xiuli Zhao
role: PRINCIPAL_INVESTIGATOR
References: