Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

• Sponsor: Beijing Tongren Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03252067
• Collaborator: Grand Pharmaceutical (China) Co., Ltd. (Other)
• Enrollment: 42
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: azithromycin eyedrop	Phase 1

Detailed Description

In this randomized, open, single-center study, 42 healthy volunteers will receive one drop of azithromycin into each eye. Azithromycin tear concentrations will be measured by LC-MS/MS at seven time points for 24 hours. Tolerability is evaluated.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tear Concentrations and Pharmacokinetics of Azithromycin Following Topical Administration of a Single Dose of Azithromycin Eyedrops in Healthy Volunteers
• Actual Study Start Date: Aug 2, 2017
• Anticipated Primary Completion Date: Oct 31, 2017
• Anticipated Study Completion Date: Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: azithromycin eyedrop 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; Tear samples will be collected using the strips.

Outcome Measures

Primary Outcome Measures

1. the maximum concentration (Cmax) [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.]

   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.

2. area under the curve (AUC) [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.]

   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.

Secondary Outcome Measures

1. AEs [24 hours]

   Ocular and systemic adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18 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.

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, 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tongren Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Beijing Tongren Hospital
• Grand Pharmaceutical (China) Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiuli Zhao, Prof., Beijing Tongren Hospital
• ClinicalTrials.gov Identifier: NCT03252067
• Other Study ID Numbers: TR-PK-201402
• First Posted: Aug 17, 2017
• Last Update Posted: Aug 17, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiuli Zhao, Prof., Beijing Tongren Hospital: Azithromycin eyedrops, pharmacokinetics, tears
• Additional relevant MeSH terms: Azithromycin; Ophthalmic Solutions

Study Results

No Results Posted as of Aug 17, 2017