Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04324905
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2020-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2020-02-28', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast', 'timeFrame': '0-24hours'}, {'measure': 'Reduced rate from baseline in 24h integrated gastric pH', 'timeFrame': '0-24hours'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '0-24hours'}, {'measure': 'Tmax', 'timeFrame': '0-24hours'}, {'measure': 't1/2', 'timeFrame': '0-24hours'}, {'measure': 'CL/F', 'timeFrame': '0-24hours'}, {'measure': 'Vd/F', 'timeFrame': '0-24hours'}, {'measure': 'AUCtau', 'timeFrame': '0-24hours'}, {'measure': 'Cmin,ss', 'timeFrame': '0-24hours'}, {'measure': 'Cmax,ss', 'timeFrame': '0-24hours'}, {'measure': 't1/2,ss', 'timeFrame': '0-24hours'}, {'measure': 'CLss/F', 'timeFrame': '0-24hours'}, {'measure': 'Vd,ss/F', 'timeFrame': '0-24hours'}, {'measure': 'Reduced rate from baseline in 24h integrated gastric pH', 'timeFrame': '0-24hours'}, {'measure': 'Duration time with integrated gastric pH>4 / 24hr', 'timeFrame': '0-24hours'}, {'measure': 'Median 24 hr gastric pH', 'timeFrame': '0-24hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'referencesModule': {'references': [{'pmid': '39289057', 'type': 'DERIVED', 'citation': 'Kim Y, Bae S, Jeon I, Kwon J, Hong SH, Kim NY, Yu KS, Jang IJ, Lee S. Pharmacokinetics and Pharmacodynamics of a Fixed-Dose Combination of Esomeprazole and Magnesium Hydroxide Compared to the Enteric-Coated Esomeprazole. Clin Ther. 2024 Nov;46(11):870-876. doi: 10.1016/j.clinthera.2024.08.006. Epub 2024 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers', 'detailedDescription': 'A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy volunteers in the age between 19 and 50 years old.\n* Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.\n* After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.\n* Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.\n\nExclusion Criteria:\n\n* Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.\n* Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to investigational product or the same component or other drugs (aspirin, antibiotics, etc.).\n* Aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.\n* Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.\n* Heavy smoker (\\>10 cigarettes/day)."}, 'identificationModule': {'nctId': 'NCT04324905', 'briefTitle': 'Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers', '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 HIP1802 to HGP1705 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'HM-ESOB-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'interventionNames': ['Drug: HIP1802', 'Drug: HGP1705']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'interventionNames': ['Drug: HIP1802', 'Drug: HGP1705']}], 'interventions': [{'name': 'HIP1802', 'type': 'DRUG', 'description': 'Test drug', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}, {'name': 'HGP1705', 'type': 'DRUG', 'description': 'Reference drug', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}