Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-29 @ 11:25 PM
Study NCT ID:
NCT01563432
Status:
COMPLETED
Last Update Posted:
2012-03-27
First Post:
2012-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-26', 'studyFirstSubmitDate': '2012-03-16', 'studyFirstSubmitQcDate': '2012-03-26', 'lastUpdatePostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic characteristics (AUClast and Cmax)', 'timeFrame': '0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 24 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['crossover', 'pharmacokinetic', 'hyperuricemia', 'gout'], 'conditions': ['Gout']}, 'descriptionModule': {'briefSummary': 'This study was designed to compare and evaluate the pharmacokinetic characteristics of febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in healthy adults; and to evaluate safety and tolerance following a single-dose administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult males aged between 20 and 45 years\n* Subjects whose weight is 50 kg or more and BMI is between 18 and 29 kg/m2\n* Subjects who were voluntarily decided to participate in the study and provided written informed consent to observe the directions\n\nExclusion Criteria:\n\n* Medical history which may influence adsorption, distribution, metabolism, excretion of the drug\n* Clinically significant active chronic disease(s)\n* Persons who are deemed ineligible for the study by the investigator according to the clinical laboratory test results or for other reasons'}, 'identificationModule': {'nctId': 'NCT01563432', 'briefTitle': 'Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Chemicals Co., Ltd.'}, 'officialTitle': 'Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Febuxostat Between TMX-67 40mg 2 Tablets and Feburic® 80mg 1 Tablet in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'TMX-67_BE_I_2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'febuxostat (TR)', 'interventionNames': ['Drug: Feburic®', 'Drug: TMX-67']}, {'type': 'EXPERIMENTAL', 'label': 'febuxostat (RT)', 'interventionNames': ['Drug: Feburic®', 'Drug: TMX-67']}], 'interventions': [{'name': 'Feburic®', 'type': 'DRUG', 'description': '80 mg\\*1 tablet', 'armGroupLabels': ['febuxostat (RT)', 'febuxostat (TR)']}, {'name': 'TMX-67', 'type': 'DRUG', 'description': '40 mg\\*2 tablets', 'armGroupLabels': ['febuxostat (RT)', 'febuxostat (TR)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ji-Young Park, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}