Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-03 @ 6:48 PM
Study NCT ID:
NCT03648333
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068838', 'term': 'Amlodipine, Valsartan Drug Combination'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-24', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-24', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (maximum concentration)', 'timeFrame': '0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour'}, {'measure': 'AUC(area under curve)', 'timeFrame': '0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['amlodipine', 'valsartan', 'hypertension'], 'conditions': ['Healthy Male Subjects']}, 'descriptionModule': {'briefSummary': 'To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults', 'detailedDescription': 'The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Years 20-45\n* Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2\n* Volunteer for the study and sign to ICF\n\nExclusion Criteria:\n\n* Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease\n* Subject with symptoms of acute disease within 28 days prior to study medication\n* Subject with history which affect on the absorption, distribution, metabolism or excretion of drug\n* Subject with clinically significant active chronic disease\n* Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) \\> Upper normal limit × 1.5 ii. Total bilirubin \\> Upper normal limit × 1.5 iii. renal failure with Creatinine clearance \\< 50mL/min\n* Clinically significant hypotension when screening period (SBP \\< 100mmHg, DBP \\< 60mmHg)\n* Positive test results for HBs Ab, HCV Ab, Syphilis regain test\n* Use of any prescription medication within 14 days prior to study medication\n* Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing\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 with known for hypersensitivity reaction to S-amlodipine, amlodipine and valsartan and dihydropyridine derivatives\n* Subject who is not able to taking the institutional standard meal\n* Subjects with whole blood donation within 60 days, component blood donation within 20 days\n* Subjects receiving blood transfusion within 30 days prior to study medication dosing\n* Participation in any clinical investigation within 60 days prior to study medication dosing\n* Continued excessive use of caffeine (caffeine \\> five cups/day), severe heavy smoker (cigarette \\> 10 cigarettes per day) and alcohol (alcohol\\>30 g/day)\n* Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice\n* Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28 days prior to study medication dosing\n* Continued serum potassium concentration abnormal status (on baseline visit, \\< 3.5 mEq/L or \\> 5.5 mEq/L)\n* Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator\n* Severe renal insufficient subjects (creatinine clearance : less than 10 mL/min)\n* Severe hepatic insufficient subjects,billiary cirrhosis, biliary obstruction and cholestasis patient\n* Combination with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate\\<60 mL/min/1.73m2)"}, 'identificationModule': {'nctId': 'NCT03648333', 'briefTitle': 'Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanlim Pharm. Co., Ltd.'}, 'officialTitle': 'Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'HL-LDV-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lodivixx tab. 5/160mg', 'description': 'S-amlodipine nicotinate (5mg as S-amlodipine), valsartan 160mg', 'interventionNames': ['Drug: Lodivixx tab. 5/160mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exforge tab. 10/160mg', 'description': 'amlodipine besylate (10mg as amlodipine), valsartan 160mg', 'interventionNames': ['Drug: Exforge tab. 10/160mg']}], 'interventions': [{'name': 'Exforge tab. 10/160mg', 'type': 'DRUG', 'otherNames': ['amlodipine besylate', 'valsartan'], 'armGroupLabels': ['Exforge tab. 10/160mg']}, {'name': 'Lodivixx tab. 5/160mg', 'type': 'DRUG', 'otherNames': ['S-amlodipine nicotinate', 'valsartan'], 'armGroupLabels': ['Lodivixx tab. 5/160mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'KyoungSook Kim, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Metro Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanlim Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}