Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-26 @ 11:04 AM
Study NCT ID:
NCT03252067
Status:
UNKNOWN
Last Update Posted:
2017-08-17
First Post:
2017-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D022125', 'term': 'Lacerations'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-14', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-14', 'lastUpdatePostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the maximum concentration (Cmax)', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'area under the curve (AUC)', 'timeFrame': '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.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'AEs', 'timeFrame': '24 hours', 'description': 'Ocular and systemic adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Azithromycin eyedrops, pharmacokinetics, tears'], 'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 45 years old, male or female;\n* BMI in the range of 19 to 24;\n* eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and fundus examination were normal, tear secretion function is normal;\n* Good compliance and voluntarily signed consent.\n\nExclusion Criteria:\n\n* Have eye disease or systemic disease;\n* physical examination, laboratory tests, ECG and chest X-ray examination abnormalities and has clinical significance;\n* HBsAg, anti-HCV, anti-HIV and TPPA positive;\n* those who used eye drops two weeks before the test and who used any dosage form of azithromycin;\n* known to azithromycin or macrolide-related varieties of allergies or serious adverse reactions;\n* need to wear contact lenses during the test;\n* history of internal surgery or laser surgery history;\n* participated in other drug clinical trials in the past three months;\n* pregnant women and lactating women, or in the growth period without taking effective contraceptive measures, menstrual period women;\n* mental illness or alcohol, history of drug abuse or inability to collaborate;\n* Any other circumstances that the investigators consider are unfit to participate in this study.'}, 'identificationModule': {'nctId': 'NCT03252067', 'briefTitle': 'Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'Tear Concentrations and Pharmacokinetics of Azithromycin Following Topical Administration of a Single Dose of Azithromycin Eyedrops in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'TR-PK-201402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'azithromycin eyedrop', 'description': "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.", 'interventionNames': ['Drug: azithromycin eyedrop']}], 'interventions': [{'name': 'azithromycin eyedrop', 'type': 'DRUG', 'description': 'Tear samples will be collected using the strips.', 'armGroupLabels': ['azithromycin eyedrop']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Wu', 'role': 'CONTACT', 'email': 'trdrug@126.com', 'phone': '010-58268486'}], 'facility': 'Beijing Tongren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Feng Wu, Master', 'role': 'CONTACT', 'email': 'trdrug@126.com', 'phone': '010-58268486'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grand Pharmaceutical (China) Co., Ltd.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Xiuli Zhao', 'investigatorAffiliation': 'Beijing Tongren Hospital'}}}}