Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-30 @ 11:10 PM
Study NCT ID:
NCT01085695
Status:
COMPLETED
Last Update Posted:
2013-05-13
First Post:
2010-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of E3810 for Healthy Japanese Male (Under Fasting Condition)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-09', 'studyFirstSubmitDate': '2010-03-11', 'studyFirstSubmitQcDate': '2010-03-11', 'lastUpdatePostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC)', 'timeFrame': 'One day'}], 'secondaryOutcomes': [{'measure': 'Vital signs, clinical laboratory screens of blood and urine, adverse event monitoring, adverse drug reaction monitoring', 'timeFrame': '13 days'}]}, 'conditionsModule': {'keywords': ['Rabeprazole', 'Japan', 'healthy Japanese male'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacokinetics of rabeprazole under fasting condition.', 'detailedDescription': 'The purpose of this study is to assess bioequivalence after single administration of the following 4 types of formulation: normal 10 mg rabeprazole tablet rabeprazole, and Type 1, Type 2, and Type 3 granule formulation containing rabeprazole 10 mg.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nSubjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19.\n\nExclusion criteria:\n\nSubjects with allergy'}, 'identificationModule': {'nctId': 'NCT01085695', 'briefTitle': 'Study of E3810 for Healthy Japanese Male (Under Fasting Condition)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Fasting Condition)', 'orgStudyIdInfo': {'id': 'E3810-J081-033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: rabeprazole']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: rabeprazole']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: rabeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: rabeprazole']}], 'interventions': [{'name': 'rabeprazole', 'type': 'DRUG', 'description': '10 mg normal tablet', 'armGroupLabels': ['1']}, {'name': 'rabeprazole', 'type': 'DRUG', 'description': 'Type 1 granule containing rabeprazole 10 mg', 'armGroupLabels': ['2']}, {'name': 'rabeprazole', 'type': 'DRUG', 'description': 'Type 2 granule containing rabeprazole 10 mg', 'armGroupLabels': ['3']}, {'name': 'rabeprazole', 'type': 'DRUG', 'description': 'Type 3 granule containing rabeprazole 10 mg', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kai Shibata', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Research Center, Eisai, Co., Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}