Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-29 @ 1:33 AM
Study NCT ID:
NCT04622358
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2020-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064750', 'term': 'Rabeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, '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': '2020-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCtau,ss(Area under the plasma drug concentration-time curve)', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluation PK Rabeprazole after multiple dose'}, {'measure': 'Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)', 'timeFrame': 'Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring', 'description': 'Evaluation PD Rabeprazole after multiple dose'}], 'secondaryOutcomes': [{'measure': 'AUCtau(Area under the plasma drug concentration-time curve)', 'timeFrame': 'Day1', 'description': 'Evaluation PK Rabeprazole after single dose'}, {'measure': 'Cmax(Maximum concentration of drug in plasma)', 'timeFrame': 'Day1', 'description': 'Evaluation PK Rabeprazole after single dose'}, {'measure': 'Tmax(Time to maximum plasma concentration)', 'timeFrame': 'Day1', 'description': 'Evaluation PK Rabeprazole after single dose'}, {'measure': 't1/2(Terminal elimination half-life)', 'timeFrame': 'Day1', 'description': 'Evaluation PK Rabeprazole after single dose'}, {'measure': 'Cmax,ss(Maximum concentration of drug in plasma at steady state)', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluation PK Rabeprazole after multiple dose'}, {'measure': 'Tmax,ss(Time to maximum plasma concentration at steady state)', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluation PK Rabeprazole after multiple dose'}, {'measure': 't1/2,ss(Terminal elimination half-life at steady state)', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluation PK Rabeprazole after multiple dose'}, {'measure': 'After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours', 'timeFrame': 'Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring', 'description': 'Evaluation PD Rabeoprazoke'}, {'measure': 'After the first administration and 7 days of repeated administration, The median pH measured for 24 hours', 'timeFrame': 'Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring', 'description': 'Evaluation PD Rabeoprazoke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214-02 to Rabeprazole in healthy volunteers.', 'detailedDescription': 'This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214-02 compared with administration of Rabeprazole in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19\\~50 years in healthy volunteers\n* BMI is more than 18.0 kg/m\\^2 , no more than 27.0 kg/m\\^2\n* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing\n\nExclusion Criteria:\n\n* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system\n* Subjects who judged ineligible by the investigator'}, 'identificationModule': {'nctId': 'NCT04622358', 'briefTitle': 'A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole', 'organization': {'class': 'INDUSTRY', 'fullName': 'Addpharma Inc.'}, 'officialTitle': 'A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-214-02 to Rabeprazole in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'AD-214PK/PD-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AD-214-02/Rabeprazole', 'description': 'Period 1 : Test Drug(AD-214-02) Period 2 : Reference Drug(Rabeprazole)', 'interventionNames': ['Drug: AD-214-02', 'Drug: Rabeprazole']}, {'type': 'EXPERIMENTAL', 'label': 'Rabeprazole/AD-214', 'description': 'Period 1 : Reference Drug(Rabeprazole) Period 2 : Test Drug(AD-214-02)', 'interventionNames': ['Drug: AD-214-02', 'Drug: Rabeprazole']}], 'interventions': [{'name': 'AD-214-02', 'type': 'DRUG', 'description': '1 tablet administered before the breakfast during 7 days', 'armGroupLabels': ['AD-214-02/Rabeprazole', 'Rabeprazole/AD-214']}, {'name': 'Rabeprazole', 'type': 'DRUG', 'description': '1 tablet administered before the breakfast during 7 days', 'armGroupLabels': ['AD-214-02/Rabeprazole', 'Rabeprazole/AD-214']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seunghwan Lee, M.D.,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addpharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}