Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-05-20 @ 1:51 PM
Study NCT ID:
NCT02011633
Status:
COMPLETED
Last Update Posted:
2014-03-11
First Post:
2013-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 500mg and Rosuvastatin 10mg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-10', 'studyFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'metformin, rosuvastatin Cmax', 'timeFrame': 'pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h'}, {'measure': 'metformin, rosuvastatin AUClast', 'timeFrame': 'pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h'}], 'secondaryOutcomes': [{'measure': 'Metformin, rosuvastatin Tmax', 'timeFrame': 'pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h'}, {'measure': 'Metformin, rosuvastatin T1/2', 'timeFrame': 'pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h'}, {'measure': 'Metformin, rosuvastatin AUCinf', 'timeFrame': 'pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'To compare the pharmacokinetic characteristics between HCP1201 tablet 500/10 mg and co-administration of metformin 500 mg plus rosuvastatin 10 mg under fasted and fed state, respectively.', 'detailedDescription': 'An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 500/10 mg and Coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg in Healthy Volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteer, age 20\\~55 years\n* The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2\n* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.\n\nExclusion Criteria:\n\n* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study\n* History of relevant drug allergies or clinically significant hypersensitivity reaction.'}, 'identificationModule': {'nctId': 'NCT02011633', 'briefTitle': 'Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 500mg and Rosuvastatin 10mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 500/10 mg and Coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'HM-MERO-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HCP1201, Part 1', 'description': 'Participants received a single oral dose of the HCP1201 500/10 mg under fasting condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).', 'interventionNames': ['Drug: HCP1201 500/10mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin and Rosuvastatin, Part1', 'description': 'Participants received a single oral dose of coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg under fasting condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).', 'interventionNames': ['Drug: Metformin SR 500mg', 'Drug: Rosuvastatin 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'HCP1201, Part 2', 'description': 'Participants received a single oral dose of the HCP1201 500/10mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).', 'interventionNames': ['Drug: HCP1201 500/10mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin and Rosuvastatin, Part 2', 'description': 'Participants received a single oral dose of coadministration of Metformin SR 500mg and Rosuvastatin 10mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).', 'interventionNames': ['Drug: Metformin SR 500mg']}], 'interventions': [{'name': 'HCP1201 500/10mg', 'type': 'DRUG', 'description': '500mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.', 'armGroupLabels': ['HCP1201, Part 1', 'HCP1201, Part 2']}, {'name': 'Metformin SR 500mg', 'type': 'DRUG', 'otherNames': ['Glucophage SR 500 mg'], 'description': 'Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.', 'armGroupLabels': ['Metformin and Rosuvastatin, Part 2', 'Metformin and Rosuvastatin, Part1']}, {'name': 'Rosuvastatin 10mg', 'type': 'DRUG', 'otherNames': ['Crestor 10mg'], 'description': 'Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.', 'armGroupLabels': ['Metformin and Rosuvastatin, Part1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Wooseong Huh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}