Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-03-12 @ 7:43 AM
Study NCT ID:
NCT02589457
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-11', 'studyFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt of Tenofovir', 'timeFrame': '0(Pre-dose) up to 72hr'}], 'secondaryOutcomes': [{'measure': 'AUCinf', 'timeFrame': '0(Pre-dose) up to 72hr'}, {'measure': 'Blood pressure', 'timeFrame': '1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day'}, {'measure': 'tmax', 'timeFrame': '0(Pre-dose) up to 72hr'}, {'measure': 't1/2β', 'timeFrame': '0(Pre-dose) up to 72hr'}, {'measure': 'Clearance/F', 'timeFrame': '0(Pre-dose) up to 72hr'}, {'measure': 'Electrocardiography', 'timeFrame': '1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day'}, {'measure': 'Physical Examination', 'timeFrame': '1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day'}, {'measure': 'Pulse rate', 'timeFrame': '1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day'}, {'measure': 'Temperature', 'timeFrame': '1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Hepatitis B virus, HIV-1 infection', 'Healthy Male Volunteer', 'Tenofovir Disoproxil Fumarate'], 'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.', 'detailedDescription': 'A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy male volunteer in the age of 19-45\n2. Body weight ≥ 55kg and in the range of calculated Ideal Body Weight ± 20%\n3. Subject without a hereditary problems, chronic disease and morbid symptom\n4. Subject who sign on an informed consent form willingly\n\nExclusion Criteria:\n\n1. Clinically significant disease with hepatobiliary, nephrological, gastrointestinal, respiratory, hepato-oncological, endocrine, urogenital, neurologic, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system\n2. Gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) or gastrointestinal surgery(except for appendectomy or herniotomy)\n3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives\n4. Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption\n5. Sitting systolic blood pressure \\> 140mmHg or \\< 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or \\< 60mmHg, pulse ≥ 100 beats per minute\n6. Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin \\> 2 x upper limit of normal range\n7. Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)\n8. The history of drug abuse or drug abuse showed a positive for urine drug test\n9. Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 1 month\n10. Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week\n11. Taking drugs have received any other investigational drug within 3 months prior to the first dosing\n12. Whole blood donation within 2 months prior to the first dosing or component blood donation within 1 months prior to the first dosing or blood transfusion within 1 month\n13. Continuously taking excessive alcohol (\\> 21 units/week; 1 unit = 10g of pure alcohol) or cannot stop drinking from 24 hours before admission to discharge\n14. Cigarette \\> 10 cigarettes a day on average for recent 3 months\n15. Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit\n16. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason"}, 'identificationModule': {'nctId': 'NCT02589457', 'briefTitle': 'Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': '163BE15028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Viread® tablet', 'description': 'Tenofovir Disoproxil Fumarate', 'interventionNames': ['Drug: Viread® tablet']}, {'type': 'EXPERIMENTAL', 'label': 'CKD-390', 'description': 'Tenofovir Disoproxil Fumarate', 'interventionNames': ['Drug: CKD-390']}], 'interventions': [{'name': 'CKD-390', 'type': 'DRUG', 'description': 'Tenofovir Disoproxil Aspartate 1T PO', 'armGroupLabels': ['CKD-390']}, {'name': 'Viread® tablet', 'type': 'DRUG', 'description': 'Tenofovir Disoproxil Fumarate 1T PO', 'armGroupLabels': ['Viread® tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '301-721', 'city': 'Daejeon', 'state': 'Jung-gu', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}], 'overallOfficials': [{'name': 'Jang Hee Hong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungnam National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}