Bacterial Conjunctivitis
Conditions
Keywords
Azithromycin eye drops, Local Pharmacokinetics
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.
Interventions
DRUGazithromycin eye drops by essex
azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),
DRUGazithromycin eye drops
azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc
Sponsors
Zhuhai Essex Bio-Pharmaceutical Company Limited
Panacea Technologies
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| AE | from the ICF signed to the end of the trial,through study completion, an average of 1 year | 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. |
| SAE | from the ICF signed to the end of the trial,through study completion, an average of 1 year | Any serious adverse events that occur during the clinical study, whether or not related to the drug should be collected. |
Countries
China
Contacts
Primary ContactXiuli Zhao, Doctor
Backup ContactSiyang Ni, Doctor
Outcome results
None listed