Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-21 @ 12:27 PM
Study NCT ID:
NCT05259020
Status:
UNKNOWN
Last Update Posted:
2022-02-28
First Post:
2022-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)', 'timeFrame': '0~72hr', 'description': 'Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: AUCt'}, {'measure': 'Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)', 'timeFrame': '0~72hr', 'description': 'Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: Cmax'}], 'secondaryOutcomes': [{'measure': 'AUCt (Free Ezetimibe)', 'timeFrame': '0~72hr', 'description': 'Free Ezetimibe: AUCt'}, {'measure': 'Cmax (Free Ezetimibe)', 'timeFrame': '0~72hr', 'description': 'Free Ezetimib: Cmax'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemias', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult volunteers aged over 19 years\n* Subjects who have over 50kg and BMI more than 18.5kg/m\\^2 and less than 29.9kg/m\\^2\n* Subjects who are eligible for this study as determined by clinical laboratory test results, urine test results, vital sign measurements, 12-lead ECG results, and physical examination findings during screening.\n* Subjects must agree to practice a medically acceptable method of birth control and should not donate sperm or eggs until 28 days after last dose of study drug.\n* Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period\n\nExclusion Criteria:\n\n* • Subject with any clinically significant cardiovascular, respiratory, endocrinology, infectious disease, ophthalmology, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease\n\n * History of gastrointestinal disease (except for appendectomy or herniotomy) or surgery (ex. Crohn's disease, ulcer) that may affect the absorption of a given drug\n * Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug\n * Subject with symptoms of acute disease within 28days prior to study medication dosing\n * Drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity:\n * Subject with a history of drug abuse or urinalysis positive\n * Subject with clinically significant active chronic disease\n * Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.\n * Genetic myopathic disorder or related family history\n * Positive test results for HBs Ab, HCV Ab, Anti HIV(AIDS), RPR Ab\n * Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)\n * Subject who cannot take standard meal in hospitalization\n * Present history of hypothyroidism or clinically significant assay\n * Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration.\n * Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing\n * Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling.\n * Subjects who judged ineligible by the investigator"}, 'identificationModule': {'nctId': 'NCT05259020', 'briefTitle': 'To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'IlDong Pharmaceutical Co Ltd'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over, Clinical Trial to Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers.', 'orgStudyIdInfo': {'id': 'ID-VARE-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ID140009', 'interventionNames': ['Combination Product: ID140009']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ID1803+ID1805', 'interventionNames': ['Combination Product: ID1803+ID1805']}], 'interventions': [{'name': 'ID140009', 'type': 'COMBINATION_PRODUCT', 'description': 'Combination Product: ID140009 Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg/ Amlodipine 10mg/ Valsartan 160mg', 'armGroupLabels': ['ID140009']}, {'name': 'ID1803+ID1805', 'type': 'COMBINATION_PRODUCT', 'description': '(Amlodipine 10mg/Valsartan 160mg)+(Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg)', 'armGroupLabels': ['ID1803+ID1805']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'MinJung Kim', 'role': 'CONTACT'}], 'facility': 'H plus yangji hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'MinJung Kim', 'role': 'CONTACT', 'email': 'mjkim90@ildong.com', 'phone': '025263179'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IlDong Pharmaceutical Co Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}