Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-02 @ 11:48 AM
Study NCT ID:
NCT04703868
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2021-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects
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': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Integrated gastric acidity', 'timeFrame': 'From Day 1 up to Day 28', 'description': 'Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose'}, {'measure': 'AUCt,ss', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}], 'secondaryOutcomes': [{'measure': 'Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose', 'timeFrame': '24 hours', 'description': 'Evaluateion PD Rabeprazole after multiple dose'}, {'measure': 'Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th dose', 'timeFrame': 'From Day 1 up to Day 28', 'description': 'Evaluateion PD Rabeprazole after multiple dose'}, {'measure': 'Mean and median gastric pH after 1st and 7th dose', 'timeFrame': 'From Day 1 up to Day 28', 'description': 'Evaluateion PD Rabeprazole after multiple dose'}, {'measure': 'AUCĪ', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 'Cmax', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 'Tmax', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 't1/2', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 'CL/F', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 'Vz/F', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 'Cmin,ss,', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 'Cmax,ss', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 'Cav,ss,', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 'Tmax,ss', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 't1/2,ss', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 'CLss/F', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}, {'measure': 'Vss/F', 'timeFrame': 'From Day 1 up to Day 29', 'description': 'Evaluateion PK Rabeprazole after multiple dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects', 'detailedDescription': 'This study is to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19\\~55 years in healthy volunteers\n* BMI is more than 18.0 kg/m\\^2 , no more than 28.0 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 were judged ineligible by the investigator'}, 'identificationModule': {'nctId': 'NCT04703868', 'briefTitle': 'A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yungjin Pharm. Co., Ltd.'}, 'officialTitle': 'A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'YJ26-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YPI-011 10/500mg', 'description': 'Part A: 1 tablet administered before the breakfast during 7 days', 'interventionNames': ['Drug: Rabeprazole Sodium 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'YPI-011 20/500mg', 'description': 'Part B: 1 tablet administered before the breakfast during 7 days', 'interventionNames': ['Drug: Rabeprazole Sodium 20mg']}], 'interventions': [{'name': 'Rabeprazole Sodium 10mg', 'type': 'DRUG', 'otherNames': ['Reference drug'], 'description': 'Part A: 1 tablet administered before the breakfast during 7 days', 'armGroupLabels': ['YPI-011 10/500mg']}, {'name': 'Rabeprazole Sodium 20mg', 'type': 'DRUG', 'otherNames': ['Reference drug'], 'description': 'Part B: 1 tablet administered before the breakfast during 7 days', 'armGroupLabels': ['YPI-011 20/500mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Daehak-ro Jongno-gu', '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yungjin Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}