Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-25 @ 1:35 AM
Study NCT ID:
NCT00991705
Status:
COMPLETED
Last Update Posted:
2009-10-08
First Post:
2009-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'C558933', 'term': 'fimasartan'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-07', 'studyFirstSubmitDate': '2009-10-07', 'studyFirstSubmitQcDate': '2009-10-07', 'lastUpdatePostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fimasartan, Atorvastatin'], 'conditions': ['Essential Hypertension']}, 'referencesModule': {'references': [{'pmid': '21765368', 'type': 'DERIVED', 'citation': 'Shin KH, Kim TE, Kim SE, Lee MG, Song IS, Yoon SH, Cho JY, Jang IJ, Shin SG, Yu KS. The effect of the newly developed angiotensin receptor II antagonist fimasartan on the pharmacokinetics of atorvastatin in relation to OATP1B1 in healthy male volunteers. J Cardiovasc Pharmacol. 2011 Nov;58(5):492-9. doi: 10.1097/FJC.0b013e31822b9092.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics of fimasartan.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 20 - 45 years\n* sex: male\n* body weight: greater than 55 kg\n* written informed consent\n\nExclusion Criteria:\n\n* known allergy to Fimasartan and atorvastatin\n* existing cardiac or hematological diseases\n* existing hepatic and renal diseases\n* existing gastrointestinal diseases\n* acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder\n* positive drug or alcohol screening\n* smokers of 10 or more cigarettes per day 3 month ago\n* participation in a clinical trial during the last 2 months prior to the start of the study'}, 'identificationModule': {'nctId': 'NCT00991705', 'briefTitle': 'A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'An Open-label, Two-treatment, Two-period, Two-sequence, Crossover Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'A657-BR-CT-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group B', 'description': 'Atorvastatin (7 days) → Fimasartan + Atorvastatin (7 days)', 'interventionNames': ['Drug: Atorvastatin', 'Drug: Fimasartan']}, {'type': 'OTHER', 'label': 'Group A', 'description': 'Fimasartan (7 days) → Fimasartan + Atorvastatin (7 days)', 'interventionNames': ['Drug: Atorvastatin', 'Drug: Fimasartan']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Fimasartan', 'type': 'DRUG', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kyung-Sang Yu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Choi, Director', 'oldOrganization': 'Boryung Pharmaceutical Co., Ltd'}}}}