Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-03-28 @ 10:50 PM
Study NCT ID:
NCT02665832
Status:
UNKNOWN
Last Update Posted:
2016-01-28
First Post:
2016-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of DWJ1351 in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C437965', 'term': 'olmesartan'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-25', 'studyFirstSubmitDate': '2016-01-20', 'studyFirstSubmitQcDate': '2016-01-25', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': '0 - 144 hr'}, {'measure': 'Cmax', 'timeFrame': '0 - 144 hr'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult male subjects aged 19 to 50 years\n* Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2\n* Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results\n* Subject who provided written informed consent to participate in this study\n\nExclusion Criteria:\n\n* Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs\n* Subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, digestive system, reproductive system, neurology, psychology, ophthalmic and skin disease\n* Subjects who had a serious clinical illness that can impact fate of drugs absorption\n* Subject who shows vital signs with the number of systolic blood pressure of ≥150 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥100mmHg or ≤66mmHg\n* Subject who have experienced drug abuse\n* Subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month)\n* Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication'}, 'identificationModule': {'nctId': 'NCT02665832', 'briefTitle': 'Study of DWJ1351 in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized, Open-label, Single-Dose, 2-Way Cross-over Study To Compare the Safety and Pharmacokinetic Characteristics of Combination of Amlodipine, Olmesartan and Rosuvastatin and DWJ1351 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWJ1351002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AB', 'description': 'Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) followed by DWJ1351', 'interventionNames': ['Drug: DWJ1351', 'Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)']}, {'type': 'EXPERIMENTAL', 'label': 'BA', 'description': 'DWJ1351 followed by Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)', 'interventionNames': ['Drug: DWJ1351', 'Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)']}], 'interventions': [{'name': 'DWJ1351', 'type': 'DRUG', 'armGroupLabels': ['AB', 'BA']}, {'name': 'Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)', 'type': 'DRUG', 'armGroupLabels': ['AB', 'BA']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sang-Joon Kim', 'role': 'CONTACT', 'email': 'sjkim050@daewoong.co.kr', 'phone': '+82 550 8708'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}