Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 7:57 AM
Study NCT ID:
NCT04322266
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2019-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.
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': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2019-09-09', 'studyFirstSubmitQcDate': '2020-03-25', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of Amlodipine', 'timeFrame': 'Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'AUClast of Amlodipine', 'timeFrame': 'Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'Cmax of Losartan', 'timeFrame': 'Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'AUClast of Losartan', 'timeFrame': 'Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'Cmax of Rosuvastatin', 'timeFrame': 'Day 1,Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'AUClast of Rosuvastatin', 'timeFrame': 'Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'Cmax of Free Ezetimibe', 'timeFrame': 'Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'AUClast of Free Ezetimibe', 'timeFrame': 'Day 1, Day15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'Cmax of EXP3174', 'timeFrame': 'Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'AUClast of EXP3174', 'timeFrame': 'Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours', 'description': 'Pharmacokinetic evaluation'}], 'secondaryOutcomes': [{'measure': 'Cmax of Total Ezetimibe', 'timeFrame': 'Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'AUClast of Total Ezetimibe', 'timeFrame': 'Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours', 'description': 'Pharmacokinetic evaluation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '38775910', 'type': 'DERIVED', 'citation': 'Park JW, Chung H, Kim JM, Kim NY, Hong SH, Kim KA, Park JY. Pharmacokinetics of a Fixed-Dose Combination Product of Amlodipine, Losartan, Ezetimibe, and Rosuvastatin and Its Comparison with Co-administration of Four Individual Components in Healthy Participants. Drugs R D. 2024 Jun;24(2):179-186. doi: 10.1007/s40268-024-00460-y. Epub 2024 May 22.'}]}, 'descriptionModule': {'briefSummary': 'An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 19\\~45 years in healthy volunteers\n2. BMI is more than 18.5 kg/m\\^2 , no more than 29.9 kg/m\\^2\n3. Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.\n4. 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': 'NCT04322266', 'briefTitle': 'A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'HM-AMOS-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1 (Reference-Test)', 'description': 'Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701', 'interventionNames': ['Drug: HCP1701', 'Drug: HCP1306', 'Drug: HGP0904', 'Drug: HGP0608']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2 (Test-Reference)', 'description': 'Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608', 'interventionNames': ['Drug: HCP1701', 'Drug: HCP1306', 'Drug: HGP0904', 'Drug: HGP0608']}], 'interventions': [{'name': 'HCP1701', 'type': 'DRUG', 'description': 'Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium', 'armGroupLabels': ['Sequence 1 (Reference-Test)', 'Sequence 2 (Test-Reference)']}, {'name': 'HCP1306', 'type': 'DRUG', 'description': 'Ezetimibe /Rosuvastatin', 'armGroupLabels': ['Sequence 1 (Reference-Test)', 'Sequence 2 (Test-Reference)']}, {'name': 'HGP0904', 'type': 'DRUG', 'description': 'Amlodipine', 'armGroupLabels': ['Sequence 1 (Reference-Test)', 'Sequence 2 (Test-Reference)']}, {'name': 'HGP0608', 'type': 'DRUG', 'description': 'Losartan potassium', 'armGroupLabels': ['Sequence 1 (Reference-Test)', 'Sequence 2 (Test-Reference)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Hospital (Anam)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}