Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-03-27 @ 5:56 PM
Study NCT ID:
NCT02125227
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
2014-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Clinical Trial to Investigate the Effect on the Pharmacokinetics of YH14755 Compared to Co-administration of Rosuvastatin and Metformin SR in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'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'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-08', 'studyFirstSubmitDate': '2014-04-24', 'studyFirstSubmitQcDate': '2014-04-28', 'lastUpdatePostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast of rosuvastatin and metformin', 'timeFrame': '0~48hr, totally 17 points'}, {'measure': 'Cmax of rosuvastatin and metformin', 'timeFrame': '0~48hr, totally 17 points'}], 'secondaryOutcomes': [{'measure': 'Tmax of rosuvastatin and metformin', 'timeFrame': '0~48hr, totally 17 points'}, {'measure': 't1/2 of rosuvastatin and metformin', 'timeFrame': '0~48hr, totally 17 points'}, {'measure': '%AUC of rosuvastatin and metformin', 'timeFrame': '0~48hr, totally 17 points'}, {'measure': 'AUCinf of rosuvastatin and metformin', 'timeFrame': '0~48hr, totally 17 points'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2\n2. Who has not suffered from clinically significant disease\n3. Provision of signed written informed consent\n\nExclusion Criteria:\n\n1. History of and clinically significant disease\n2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.\n3. Administration of other investigational products within 3 months prior to the first dosing.\n4. Administration of herbal medicine within 4 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).\n5. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.'}, 'identificationModule': {'nctId': 'NCT02125227', 'briefTitle': 'Phase 1 Clinical Trial to Investigate the Effect on the Pharmacokinetics of YH14755 Compared to Co-administration of Rosuvastatin and Metformin SR in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'A Randomized, Open-label, Single-dose, 2-Way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755', 'orgStudyIdInfo': {'id': 'YH14755-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 of Study A', 'description': 'single dosing of Rosuvastatin and Metformin 14 days later, single dosing of YH14755', 'interventionNames': ['Drug: Rosuvastatin, Metformin, YH14755']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 of Study A', 'description': 'single dosing of YH14755 14 days later, single dosing of Rosuvastatin and Metformin', 'interventionNames': ['Drug: Rosuvastatin, Metformin, YH14755']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1 of Study B', 'description': 'single dosing of YH14755 with fasting state 14 days later, single dosing of YH14755 after having breakfast', 'interventionNames': ['Drug: YH14755']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 of Study B', 'description': 'single dosing of YH14755 after having breakfast 14 days later, single dosing of YH14755 with fasting state', 'interventionNames': ['Drug: YH14755']}], 'interventions': [{'name': 'Rosuvastatin, Metformin, YH14755', 'type': 'DRUG', 'otherNames': ['Crestor, GlucodaunOR, YH14755'], 'description': 'single dose', 'armGroupLabels': ['Group 1 of Study A', 'Group 2 of Study A']}, {'name': 'YH14755', 'type': 'DRUG', 'description': 'single dose', 'armGroupLabels': ['Group 1 of Study B', 'Group 2 of Study B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '561712', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}], 'overallOfficials': [{'name': 'Mingul Kim, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}