Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT05155995
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2021-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2001 and Co-administration of Each Component 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': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt', 'timeFrame': '0~48hr', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'Cmax', 'timeFrame': '0~48hr', 'description': 'Pharmacokinetic evaluation'}], 'secondaryOutcomes': [{'measure': 'AUCinf', 'timeFrame': '0~48hr', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'Tmax', 'timeFrame': '0~48hr', 'description': 'Pharmacokinetic evaluation'}, {'measure': 't1/2', 'timeFrame': '0~48hr', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'CL/F', 'timeFrame': '0~48hr', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'Vd/F', 'timeFrame': '0~48hr', 'description': 'Pharmacokinetic evaluation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2001 and co-administration of each component in fasting and fed conditions respectively in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '54 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19\\~54 years in healthy volunteers 19 kg/m\\^2 ≤ BMI \\< 28 kg/m\\^2, weight(men) ≥55kg / weight(women) ≥45kg\n* 90 mmHg ≤ SBP \\<140 mmHg, 50 mmHg ≤ DBP \\<90 mmHg\n* agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.\n* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial\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 judged ineligible by the investigator'}, 'identificationModule': {'nctId': 'NCT05155995', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics and Safety Between HCP2001 and Co-administration of Each Component in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between After Administration of a Fixed-dose Combination Drug of HCP2001 and Co-administration of Each Component in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'HM-DATAM-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102\n\nPeriod 2: Fasted state + HCP2001', 'interventionNames': ['Drug: HCP2001', 'Drug: RLD2007', 'Drug: RLD2008', 'Drug: RLD2102']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Period 1: Fasted state + HCP2001\n\nPeriod 2: Fasted state + RLD2007 +RLD2008 + RLD2102', 'interventionNames': ['Drug: HCP2001', 'Drug: RLD2007', 'Drug: RLD2008', 'Drug: RLD2102']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102\n\nPeriod 2: High fat diet + HCP2001', 'interventionNames': ['Drug: HCP2001', 'Drug: RLD2007', 'Drug: RLD2008', 'Drug: RLD2102']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': 'Period 1: High fat diet + HCP2001\n\nPeriod 2: High fat diet + RLD2007 +RLD2008 + RLD2102', 'interventionNames': ['Drug: HCP2001', 'Drug: RLD2007', 'Drug: RLD2008', 'Drug: RLD2102']}], 'interventions': [{'name': 'HCP2001', 'type': 'DRUG', 'description': 'Take it once per period.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}, {'name': 'RLD2007', 'type': 'DRUG', 'description': 'Take it once per period.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}, {'name': 'RLD2008', 'type': 'DRUG', 'description': 'Take it once per period.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}, {'name': 'RLD2102', 'type': 'DRUG', 'description': 'Take it once per period.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}], 'overallOfficials': [{'name': 'Mingeul Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}