Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT03372850
Status:
UNKNOWN
Last Update Posted:
2018-01-17
First Post:
2017-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-14', 'studyFirstSubmitDate': '2017-12-08', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'After first administration and repeated administration for 7 days, The percentage of decrease in integrated gastric acidity compared to baseline by time', 'timeFrame': '1Day(Full time) pH monitoring, 7Day 24h (Full time) pH monitoring', 'description': 'exploratory endpoint'}], 'primaryOutcomes': [{'measure': 'AUClast of esomeprazole', 'timeFrame': '1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'After 7days of repeated administration, Total gastric acidity decrease rate versus baseline for 24 hours', 'timeFrame': '7Day 24h(Full time) pH monitoring', 'description': 'pharmacodynamic evaluation'}], 'secondaryOutcomes': [{'measure': 'AUCinf of esomeprazole', 'timeFrame': '1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Cmax of esomeprazole', 'timeFrame': '1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Tmax of esomeprazole', 'timeFrame': '1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Terminal Half-life of esomeprazole', 'timeFrame': '1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'CL/F of esomeprazole', 'timeFrame': '1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Vd/F of esomeprazole', 'timeFrame': '1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Ctrough', 'timeFrame': '1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 51 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 2 Day 0 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Ctrough,ss', 'timeFrame': '1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'PTF', 'timeFrame': '1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'RActrough', 'timeFrame': '1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'After the first administration of esomeprazole, The rate of decrease of integrated gastric acidity compared to baseline for 24 hours', 'timeFrame': '1Day 24h pH monitoring', 'description': 'pharmacodynamic evaluation'}, {'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': '1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring', 'description': 'pharmacodynamic evaluation'}, {'measure': 'After the first administration and 7 days of repeated administration, The median pH measured for 24 hours', 'timeFrame': '1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring', 'description': 'pharmacodynamic evaluation'}, {'measure': 'After first administration and 7 days of repeated administration, Total gastric acidity reduction rate versus baseline between 12hours and 24 hours', 'timeFrame': '1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h', 'description': 'pharmacodynamic evaluation'}, {'measure': 'After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher between 12hours and 24 hours', 'timeFrame': '1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h', 'description': 'pharmacodynamic evaluation'}, {'measure': 'After the first dose and 7 days of repeated dosing, The median pH measured between 12hours and 24 hours', 'timeFrame': '1Day (12~24h) pH monitoring, 7Day (12~24h) pH monitoring', 'description': 'pharmacodynamic evaluation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers', 'detailedDescription': 'This study is a 2-part study, where in Part A, the 40 mg dose will be performed followed by the 20 mg dose in Part B.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 19\\~50 years in healthy male volunteers\n2. BMI is more than 18 kg/m\\^2 , no more than 27.0 kg/m\\^2\n3. 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\n1. 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\n2. Subjects who judged ineligible by the investigator'}, 'identificationModule': {'nctId': 'NCT03372850', 'briefTitle': 'Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'HM-ESOM-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence Group 1', 'description': 'Period 1: Reference Drug(HGP1705) Period 2: Test Drug(HIP1601)', 'interventionNames': ['Drug: HIP1601', 'Drug: HGP1705']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence Group 2', 'description': 'Period 1: Test Drug(HIP1601) Period 2: Reference Drug(HGP1705)', 'interventionNames': ['Drug: HIP1601', 'Drug: HGP1705']}], 'interventions': [{'name': 'HIP1601', 'type': 'DRUG', 'otherNames': ['Esomeprazole (40 mg or 20 mg)'], 'description': 'Test Drug', 'armGroupLabels': ['Sequence Group 1', 'Sequence Group 2']}, {'name': 'HGP1705', 'type': 'DRUG', 'otherNames': ['Nexium(esomeprazole 40 mg or 20 mg)'], 'description': 'Reference Drug', 'armGroupLabels': ['Sequence Group 1', 'Sequence Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Injin Jang, M.D, Ph.D.', 'role': 'CONTACT'}, {'name': 'In-Jin Jang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sujin Kim, Pharm.D.', 'role': 'CONTACT', 'email': 'sjk9053@hanmi.co.kr', 'phone': '+821065589053'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}