Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT02127320
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2014-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-11', 'studyFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2014-04-29', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rosuvastatin AUCτ,ss', 'timeFrame': '1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h'}, {'measure': 'Rosuvastatin Cmax,ss', 'timeFrame': '1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h'}, {'measure': 'Ezetimibe Cmax,ss', 'timeFrame': '1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h'}, {'measure': 'Ezetimibe AUCτ,ss', 'timeFrame': '1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h'}], 'secondaryOutcomes': [{'measure': 'Rosuvastatin Tmax,ss', 'timeFrame': '1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h'}, {'measure': 'Rosuvastatin t1/2β', 'timeFrame': '1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h'}, {'measure': 'Ezetimibe Tmax,ss', 'timeFrame': '1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h'}, {'measure': 'Ezetimibe t1/2β', 'timeFrame': '1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the pharmacokinetic drug interactions between Rosuvastatin and Ezetimibe in Healthy Male Subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteer, age 19\\~45 years\n* The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2\n* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the 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\n* History of relevant drug allergies or clinically significant hypersensitivity reaction.'}, 'identificationModule': {'nctId': 'NCT02127320', 'briefTitle': 'Investigating the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'HM-ROZE-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Rosuvastatin 20mg → Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg', 'interventionNames': ['Drug: Rosuvastatin 20mg', 'Drug: Ezetimibe 10mg', 'Drug: Rosuvastatin 20mg + Ezetimibe 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Rosuvastatin 20mg and Ezetimibe 10mg→ Rosuvastatin 20mg → Ezetimibe 10mg', 'interventionNames': ['Drug: Rosuvastatin 20mg', 'Drug: Ezetimibe 10mg', 'Drug: Rosuvastatin 20mg + Ezetimibe 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg → Rosuvastatin 20mg', 'interventionNames': ['Drug: Rosuvastatin 20mg', 'Drug: Ezetimibe 10mg', 'Drug: Rosuvastatin 20mg + Ezetimibe 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': 'Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg → Rosuvastatin 20mg', 'interventionNames': ['Drug: Rosuvastatin 20mg', 'Drug: Ezetimibe 10mg', 'Drug: Rosuvastatin 20mg + Ezetimibe 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5', 'description': 'Ezetimibe 10mg → Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg', 'interventionNames': ['Drug: Rosuvastatin 20mg', 'Drug: Ezetimibe 10mg', 'Drug: Rosuvastatin 20mg + Ezetimibe 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 6', 'description': 'Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg', 'interventionNames': ['Drug: Rosuvastatin 20mg', 'Drug: Ezetimibe 10mg', 'Drug: Rosuvastatin 20mg + Ezetimibe 10mg']}], 'interventions': [{'name': 'Rosuvastatin 20mg', 'type': 'DRUG', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'Ezetimibe 10mg', 'type': 'DRUG', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'Rosuvastatin 20mg + Ezetimibe 10mg', 'type': 'DRUG', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul, Korea, Republic of', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyeong-Seok Lim, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}