Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-26 @ 11:55 AM
Study NCT ID:
NCT01779492
Status:
COMPLETED
Last Update Posted:
2014-11-13
First Post:
2013-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-11', 'studyFirstSubmitDate': '2013-01-28', 'studyFirstSubmitQcDate': '2013-01-28', 'lastUpdatePostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax,ss', 'timeFrame': '48h', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 'AUCτ', 'timeFrame': '24h', 'description': 'Pharmacokinetic of Oxycodone'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': '48h', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 't1/2', 'timeFrame': '48h', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 'Vz/f', 'timeFrame': '48h', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 'CL/F', 'timeFrame': '48h', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 'Cmin,ss', 'timeFrame': '48h', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 'Cave,ss', 'timeFrame': '48h', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 'degree og fluctuation', 'timeFrame': '48h', 'description': 'Pharmacokinetic of Oxycodone\n\n(Cmax,ss-Cmin,ss)/Cave,ss'}, {'measure': 'swing', 'timeFrame': '48h', 'description': 'Pharmacokinetic of Oxycodone\n\n(Cmax,ss-Cmin,ss)/Cmin,ss'}, {'measure': 'R', 'timeFrame': '48h', 'description': 'Pharmacokinetic of Oxycodone\n\nAccumulation index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oxycodone, controlled release formulation'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.', 'detailedDescription': 'GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20\\~45 years old, Healthy Adult Male Subject\n* Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%\n\nExclusion Criteria:\n\n* ALT or AST \\> 1.25 times (Upper Normal Range)\n* Total Bilirubin \\> 1.5 times (Upper Normal Range)\n* CPK \\> 2 times (Upper Normal Range)\n* BUN or Creatinine \\> Normal Range\n* Systolic BP \\> 160mmHg or \\< 80mmHg, Diastolic BP \\> 100mmHg or \\< 50mmHg'}, 'identificationModule': {'nctId': 'NCT01779492', 'briefTitle': 'A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'GL Pharm Tech Corporation'}, 'officialTitle': 'A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'GL2907-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GL2907', 'description': 'Oxycodone HCl 20mg', 'interventionNames': ['Drug: GL2907']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxycontine CR 10mg', 'description': 'Oxycodone HCl 10mg', 'interventionNames': ['Drug: Oxycontine CR 10mg']}], 'interventions': [{'name': 'GL2907', 'type': 'DRUG', 'otherNames': ['Oxycodone HCl 20mg'], 'description': 'once a day', 'armGroupLabels': ['GL2907']}, {'name': 'Oxycontine CR 10mg', 'type': 'DRUG', 'otherNames': ['Oxycodone HCl 10mg'], 'description': 'twice a day', 'armGroupLabels': ['Oxycontine CR 10mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'AJOU University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Doo-Yeoun Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GL Pharm Tech Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}