Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-03 @ 12:25 PM
Study NCT ID:
NCT03980756
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2019-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005756', 'term': 'Gastritis'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004341', 'term': 'Drug Evaluation'}, {'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D000076722', 'term': 'Drug Development'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'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': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-06-06', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-27', '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 esomeprazole after multiple dose'}, {'measure': 'Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)', 'timeFrame': 'Day1 24hrs pH monitoring, Day7 24hrs pH monitoring', 'description': 'Evaluation PD esomeprazole after multiple dose'}], 'secondaryOutcomes': [{'measure': 'AUCtau(Area under the plasma drug concentration-time curve)', 'timeFrame': 'Day1', 'description': 'Evaluation PK esomeprazole after single dose'}, {'measure': 'Cmax(Maximum concentration of drug in plasma)', 'timeFrame': 'Day1', 'description': 'Evaluation PK esomeprazole after single dose'}, {'measure': 'Tmax(Time to maximum plasma concentration)', 'timeFrame': 'Day1', 'description': 'Evaluation PK esomeprazole after single dose'}, {'measure': 't1/2(Terminal elimination half-life)', 'timeFrame': 'Day1', 'description': 'Evaluation PK esomeprazole after single dose'}, {'measure': 'CL/F(Apparent clearance)', 'timeFrame': 'Day1', 'description': 'Evaluation PK esomeprazole after single dose'}, {'measure': 'Vd/F(Apparent volume of distribution)', 'timeFrame': 'Day1', 'description': 'Evaluation PK esomeprazole 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 esomeprazole after multiple dose'}, {'measure': 'Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluation PK esomeprazole after multiple dose'}, {'measure': 'Cav,ss(Average concentration of drug in plasma at steady state)', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluation PK esomeprazole 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 esomeprazole 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 esomeprazole after multiple dose'}, {'measure': 'CLss/F(Apparent Clearance at steady state)', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluation PK esomeprazole after multiple dose'}, {'measure': 'Vss/F(Apparent Volume of distribution at steady state)', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluation PK esomeprazole after multiple dose'}, {'measure': 'PTF(Peak trough fluctuation over one dosing interal at steady state)', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluation PK esomeprazole after multiple dose'}, {'measure': 'After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours', 'timeFrame': 'Day1 24hrs pH monitoring', 'description': 'Evaluation PD esomeprazole'}, {'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 24hrs pH monitoring, Day7 24hrs pH monitoring', 'description': 'Evaluation PD esomeprazole'}, {'measure': 'After the first administration and 7 days of repeated administration, The median pH measured for 24 hours', 'timeFrame': 'Day1 24hrs pH monitoring, Day7 24hrs pH monitoring', 'description': 'Evaluation PD esomeprazole'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastritis']}, 'descriptionModule': {'briefSummary': 'A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.', 'detailedDescription': 'This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of AD-206 compared with administration of Esomeprazole in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19\\~50 years in healthy male volunteers\n* BMI is more than 18 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': 'NCT03980756', 'briefTitle': 'A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole', 'organization': {'class': 'INDUSTRY', 'fullName': 'Addpharma Inc.'}, 'officialTitle': 'A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-206 to Esomeprazole in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'AD-206PK/PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A1', 'description': 'Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg)', 'interventionNames': ['Drug: AD-206 20mg', 'Drug: Esomeprazole 20mg']}, {'type': 'EXPERIMENTAL', 'label': 'Group A2', 'description': 'Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg)', 'interventionNames': ['Drug: AD-206 20mg', 'Drug: Esomeprazole 20mg']}, {'type': 'EXPERIMENTAL', 'label': 'Group B1', 'description': 'Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg)', 'interventionNames': ['Drug: AD-206 40mg', 'Drug: Esomeprazole 40mg']}, {'type': 'EXPERIMENTAL', 'label': 'Group B2', 'description': 'Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg)', 'interventionNames': ['Drug: AD-206 40mg', 'Drug: Esomeprazole 40mg']}], 'interventions': [{'name': 'AD-206 20mg', 'type': 'DRUG', 'otherNames': ['Test drug'], 'description': '1 tablet administered before the breakfast during 7 days', 'armGroupLabels': ['Group A1', 'Group A2']}, {'name': 'Esomeprazole 20mg', 'type': 'DRUG', 'otherNames': ['Reference Drug'], 'description': '1 tablet administered before the breakfast during 7 days', 'armGroupLabels': ['Group A1', 'Group A2']}, {'name': 'AD-206 40mg', 'type': 'DRUG', 'otherNames': ['Test drug'], 'description': '1 tablet administered before the breakfast during 7 days', 'armGroupLabels': ['Group B1', 'Group B2']}, {'name': 'Esomeprazole 40mg', 'type': 'DRUG', 'otherNames': ['Reference Drug'], 'description': '1 tablet administered before the breakfast during 7 days', 'armGroupLabels': ['Group B1', 'Group B2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In-Jin Jang, 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'}}}}