Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-01 @ 8:25 PM
Study NCT ID:
NCT01568450
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2012-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL 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': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-25', 'studyFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2012-03-30', 'lastUpdatePostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '48hr', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 'AUC(0-24h)', 'timeFrame': '24 hr', 'description': 'Pharmacokinetic of Oxycodone'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': '48 hr', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 't1/2', 'timeFrame': '48 hr', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 'Vz/F', 'timeFrame': '48 hr', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 'CL/F', 'timeFrame': '48 hr', 'description': 'Pharmacokinetic of Oxycodone'}, {'measure': 'Safety Monitoring', 'timeFrame': '27 days', 'description': 'Adverse Event, Vital sign, 12-lead ECG, Physical Exam, Laboratory test'}]}, '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.\n\nGL2907 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* ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%\n\nExclusion Criteria:\n\n* ALT or AST \\> 1.25(Upper Normal Range)\n* Total Bilirubin \\> 1.5 (Upper Normal Range)\n* BUN or Creatinine \\> Normal Range\n* Systolic BP \\> 160mmHg or \\< 80mmHg, Diastolic BP \\> 100mmHg or \\< 50mmHg'}, 'identificationModule': {'nctId': 'NCT01568450', 'acronym': 'GL2907-101', 'briefTitle': 'A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'GL Pharm Tech Corporation'}, 'officialTitle': 'A Randomized, Open-label, Single-dose, Crossover Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'GL2907-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GL2907 XL 20mg (Oxycodone 20mg, fasted)', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'GL2907 XL 20mg (Oxycodone 20mg, after high fat meal)', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxycontin CR 10mg (Oxycodone 10mg, fasted)', 'interventionNames': ['Drug: Oxycodone']}], 'interventions': [{'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Oxycodone XL 20mg(20mg once a day, fasted)', 'armGroupLabels': ['GL2907 XL 20mg (Oxycodone 20mg, fasted)']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Oxycodone XL 20mg/day(20mg once a day, after high fat meal)', 'armGroupLabels': ['GL2907 XL 20mg (Oxycodone 20mg, after high fat meal)']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Oxycodone 20mg/day (10mg twice a day, fasted)', 'armGroupLabels': ['Oxycontin CR 10mg (Oxycodone 10mg, fasted)']}]}, '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'}}}}