Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-02-23 @ 8:02 PM
Study NCT ID:
NCT04690868
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare PK, PD and Safety of the AD-213-A and AD-2131
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-25', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-27', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCtau', 'timeFrame': 'From Day 1 up to Day 17', 'description': 'Evaluation PK after multiple dose'}, {'measure': 'Integrated gastric acidity(%Decrease form baseline)', 'timeFrame': '4 times from Day -1 to Day 17', 'description': 'Evaluation PD after multiple dose'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Day 1', 'description': 'Evaluation PK after single dose'}, {'measure': 'AUClast', 'timeFrame': 'Day 1', 'description': 'Evaluation PK after single dose'}, {'measure': 'AUCinf', 'timeFrame': 'Day 1', 'description': 'Evaluation PK after single dose'}, {'measure': 'Tmax', 'timeFrame': 'Day 1', 'description': 'Evaluation PK after single dose'}, {'measure': 't1/2', 'timeFrame': 'Day 1', 'description': 'Evaluation PK after single dose'}, {'measure': 'CL/F', 'timeFrame': 'Day 1', 'description': 'Evaluation PK after single dose'}, {'measure': 'Vd/F', 'timeFrame': 'Day 1', 'description': 'Evaluation PK after single dose'}, {'measure': 'Cmax,ss', 'timeFrame': 'From Day 1 up to Day 17', 'description': 'Evaluation PK after multiple dose'}, {'measure': 'Cmin,ss', 'timeFrame': 'From Day 1 up to Day 17', 'description': 'Evaluation PK after multiple dose'}, {'measure': 'AUCinf', 'timeFrame': 'From Day 1 up to Day 17', 'description': 'Evaluation PK after multiple dose'}, {'measure': 'Tmax,ss', 'timeFrame': 'From Day 1 up to Day 17', 'description': 'Evaluation PK after multiple dose'}, {'measure': 't1/2', 'timeFrame': 'From Day 1 up to Day 17', 'description': 'Evaluation PK after multiple dose'}, {'measure': 'CLss/F', 'timeFrame': 'From Day 1 up to Day 17', 'description': 'Evaluation PK after multiple dose'}, {'measure': 'Vdss/F', 'timeFrame': 'From Day 1 up to Day 17', 'description': 'Evaluation PK after multiple dose'}, {'measure': 'Integrated gastric acidity(Variations form baseline)', 'timeFrame': '4 times from Day -1 to Day 17', 'description': 'Evaluation PD after multiple dose'}, {'measure': 'Percentage of time to maintain gastric pH 4.0 or higher', 'timeFrame': '4 times from Day -1 to Day 17', 'description': 'Evaluation PD after multiple dose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroesophagus Reflux Disease']}, 'descriptionModule': {'briefSummary': 'A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults over 19 years of age.\n* Weight is more than 50kg and BMI is more than 18.0 kg/m\\^2 , no more than 27.0 kg/m\\^2.\n* Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials.\n* Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.\n\nExclusion Criteria:\n\n* A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug.\n* As a result of laboratory tests, the following figures: ALT or AST or total bilirubin \\> 1.5 times upper limit of normal range.\n* As a result of laboratory tests, the following figures: Creatinine clearance \\< 80mL/min.\n* Subjects who judged ineligible by the investigator.'}, 'identificationModule': {'nctId': 'NCT04690868', 'briefTitle': 'A Study to Compare PK, PD and Safety of the AD-213-A and AD-2131', 'organization': {'class': 'INDUSTRY', 'fullName': 'Addpharma Inc.'}, 'officialTitle': 'A Randomized, Open Label, Multi Dose, Cross Over Design Clinical Study to Evaluate the Pharmacokinetic Pharmacodynamic Characteristics and Safety of AD-213-A and AD-2131 After Oral Administration in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'AD-213PK/PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARM 1', 'description': 'Period 1 : Reference Drug(AD-2131) Period 2 : Test Drug(AD-213-A)', 'interventionNames': ['Drug: AD-213-A', 'Drug: AD-2131']}, {'type': 'EXPERIMENTAL', 'label': 'ARM 2', 'description': 'Period 1 : Test Drug(AD-213-A) Period 2 : Reference Drug(AD-2131)', 'interventionNames': ['Drug: AD-213-A', 'Drug: AD-2131']}], 'interventions': [{'name': 'AD-213-A', 'type': 'DRUG', 'description': '1 tablet administered before the breakfast during 5 days', 'armGroupLabels': ['ARM 1', 'ARM 2']}, {'name': 'AD-2131', 'type': 'DRUG', 'description': '1 tablet administered before the breakfast during 5 days', 'armGroupLabels': ['ARM 1', 'ARM 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addpharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}