Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-03-27 @ 7:07 PM
Study NCT ID:
NCT03017950
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2017-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Drug-drug Interaction of CKD-330 and D086
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-10', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCτ,ss of Candesartan and Amlodipine', 'timeFrame': 'Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30'}, {'measure': 'AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin', 'timeFrame': 'Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Hyperlipidemias']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is examining and comparing the pharmacokinetic drug interaction and safety of both single administration and combination administration of CKD-330 and D086 to healthy male subjects', 'detailedDescription': 'An open-label, randomized, multiple-dose, 2-sequence, 2-period, 2-treatment, crossover study\n\nPart1: Examining how D086 affects pharmacokinetics of CKD-330. Part2: Examining how CKD-330 affects pharmacokinetics of D086.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult males age of between 19 - 45 on the day of screening.\n2. Body mass index(BMI) between 18.0 - 29.0 kg/m\\^2 and weight ≥ 55kg (Body mass index (BMI) = weight (kg) / height (m)\\^2)\n3. Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.\n4. Not abnormal or not clinically significant lab values.\n5. Subjects who signed informed consent form with good understandings after explanations by investigators.\n\nExclusion Criteria:\n\n1. No history or presence of clinically significant cardiac, respiratory, neurological, endocrine, metal and renal diseases and liver and kidney diseases.\n2. Subjects showing angioedema as an adverse reaction to ACE inhibitors\n3. Primary Hyperaldosteronism\n4. History or family history of myopathy\n5. Subjects with mental diseases or drug addiction\n6. Allergic reactions to candesartan or amlodipine or atorvastatin\n7. Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.\n8. Hypotension(SBP ≤100mmHg or DBP≤55mnHg) or hypertension ( SNP ≥ 150mmHg, DBP ≥95mmHg) on the day of screening\n9. Subjects who experienced gastrointestinal diseases or surgeries which can affect absorption of Investigational product\n10. Subjects with abnormal lab values at least one below\n\n (AST or ALT\\>2 fold of upper normal limit, Total bilirubin\\>2 fold of upper normal limit, CPK\\>2 fold of upper normal limit, K \\<3.5mEq/L or \\>5.5mEq/L, Estimated Glomerular filtration rate\\<60mL/min/1.73m2 by Modification)\n11. Continuous drinking (over 21 units/week, 1 unit= 10g=12.5mL of pure alcohol), heavy smoker(\\> 10 cigarettes per day) and unable to stop drinking during clinical trials\n12. Subjects who previously participated in other clinical trials within 90 days\n13. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days\n14. Subjects who were administered below medications within 30 days (cyclosporin, erythromycin, clarithromycin, lopinavir, ritonavir, itraconazole, ketoconazole, rifampicin, barbiturate : theses medicines could affect absorption, metabolism, distribution and excretion of candesartan,amlodipine and atorvastatin)\n15. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.\n16. Subjects who have taken any diets affecting absorption, metabolism, distribution and excretion of investigational products (especially grapefruit juice).\n17. Subjects who are in conditions impossible participating in the clinical trials following other laboratory tests.\n18. Unable to use contraceptions.'}, 'identificationModule': {'nctId': 'NCT03017950', 'briefTitle': 'Pharmacokinetic Drug-drug Interaction of CKD-330 and D086', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Phase I Clinical Trial to Evaluate the Pharmacokinetic Drug-drug Interaction of CKD-330 and D086 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': '170DDI16017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part1 (A)', 'description': 'Number of Subjects: 10\n\nNumber of days for Period 1: 8\n\nNumber of days for Period 2: 8\n\nNumber of days for wash-out between period 1 and period 2: 14\n\nIPs for Period 1: CKD-330\n\nIPs for Period 2: CKD-330 + D086', 'interventionNames': ['Drug: CKD-330', 'Drug: CKD-330 + D086']}, {'type': 'EXPERIMENTAL', 'label': 'Part1 (B)', 'description': 'Number of Subjects: 10\n\nNumber of days for Period 1: 8\n\nNumber of days for Period 2: 8\n\nNumber of days for wash-out between period 1 and period 2: 14\n\nIPs for Period 1: CKD-330 + D086\n\nIPs for Period 2: CKD-330', 'interventionNames': ['Drug: CKD-330', 'Drug: CKD-330 + D086']}, {'type': 'EXPERIMENTAL', 'label': 'Part2 (A)', 'description': 'Number of Subjects: 30\n\nNumber of days for Period 1: 8\n\nNumber of days for Period 2: 8\n\nNumber of days for wash-out between period 1 and period 2: 14\n\nIPs for Period 1: D086\n\nIPs for Period 2: CKD-330 + D086', 'interventionNames': ['Drug: D086', 'Drug: CKD-330 + D086']}, {'type': 'EXPERIMENTAL', 'label': 'Part2 (B)', 'description': 'Number of Subjects: 30\n\nNumber of days for Period 1: 8\n\nNumber of days for Period 2: 8\n\nNumber of days for wash-out between period 1 and period 2: 14\n\nIPs for Period 1: CKD-330 + D086\n\nIPs for Period 2: D086', 'interventionNames': ['Drug: D086', 'Drug: CKD-330 + D086']}], 'interventions': [{'name': 'CKD-330', 'type': 'DRUG', 'armGroupLabels': ['Part1 (A)', 'Part1 (B)']}, {'name': 'D086', 'type': 'DRUG', 'armGroupLabels': ['Part2 (A)', 'Part2 (B)']}, {'name': 'CKD-330 + D086', 'type': 'DRUG', 'armGroupLabels': ['Part1 (A)', 'Part1 (B)', 'Part2 (A)', 'Part2 (B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}