Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT01870102
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2013-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR and Pelubiprofen SR (as a Pelubiprofen 45 mg) Tablet in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C040375', 'term': 'pelubiprofen'}, {'id': 'C494814', 'term': 'BID protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-13', 'studyFirstSubmitDate': '2013-06-03', 'studyFirstSubmitQcDate': '2013-06-03', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(Part1) Cmax,ss of Pelubiprofen IR (Pelubiprofen 30mg)', 'timeFrame': '0(pre-dose), 0.25h, 0.5.h, 0.75h, 1h, 1.5h, 2h, 4h, 6h, 6.5h, 7h, 8h, 12h, 12.5h, 13h, 14h, 24h, 60h, 72h, 72.25h, 72.5h, 72.75h, 73h, 73.5h, 74h, 76h, 78h, 80h, 84h, 96h (total 30 times)'}, {'measure': '(Part1) Cmax,ss of Pelubiprofen SR (Pelubiprofen 45 mg)', 'timeFrame': '0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 13h, 14h, 16h, 24h, 60h, 72h, 72.5h, 73h, 73.5h, 74h, 74,5h. 75h. 75.5h, 76h, 77h, 78h, 80h, 84h, 96h (total 32 times)'}, {'measure': '(Part1) Dose normalized AUCτ,ss of Pelubiprofen IR (Pelubiprofen 30mg)', 'timeFrame': '0(pre-dose), 0.25h, 0.5.h, 0.75h, 1h, 1.5h, 2h, 4h, 6h, 6.5h, 7h, 8h, 12h, 12.5h, 13h, 14h, 24h, 60h, 72h, 72.25h, 72.5h, 72.75h, 73h, 73.5h, 74h, 76h, 78h, 80h, 84h, 96h (total 30 times)'}, {'measure': '(Part1) Dose normalized AUCτ,ss of Pelubiprofen SR (Pelubiprofen 45 mg)', 'timeFrame': '0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 13h, 14h, 16h, 24h, 60h, 72h, 72.5h, 73h, 73.5h, 74h, 74,5h. 75h. 75.5h, 76h, 77h, 78h, 80h, 84h, 96h (total 32 times)'}, {'measure': '(Part2) Cmax of Pelubiprofen IR (Pelubiprofen 30mg)', 'timeFrame': '0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times)'}, {'measure': '(Part2) Cmax of Pelubiprofen SR (Pelubiprofen 45 mg)', 'timeFrame': '0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times)'}, {'measure': '(Part2) AUClast of Pelubiprofen IR (Pelubiprofen 30mg)', 'timeFrame': '0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times)'}, {'measure': '(Part2) AUClast of Pelubiprofen SR (Pelubiprofen 45 mg)', 'timeFrame': '0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times)'}]}, 'conditionsModule': {'conditions': ['Healthy Males']}, 'descriptionModule': {'briefSummary': 'Part 1 : A randomized, open Label, multiple doses, cross-over, phase I trial to investigate the pharmacokinetics of Pelubiprofen IR (Pelubiprofen 30mg) TID and Pelubiprofen SR (Pelubiprofen 45 mg) BID in healthy male volunteers Part 2 : A randomized, open label, single dose, cross-over, Phase I trial to investigate the food effect of Pelubiprofen SR (Pelubiprofen 45 mg) in healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult healthy males aged 20\\~40 years\n* BMI valued over 19 kg/m2, below 27 kg/m2\n* Subjects whose blood pressure ; systolic BP over 90mmHg below 140mmHg, diastolic BP over 60mmHg below 90mmHg, stable station pulse over 45 bpm below 100 bpm\n* Subjects who agree with double protective contraception or able to certificate already sterilization operation 1 day before administration of Investigational new drugs within 14 days after completion\n* Subjects who voluntarily agreed with written consent\n\nExclusion Criteria:\n\n* Subjects with clinically significant disease or past medical history in hepatic, renal, GI tract, respiratory, musculoskeletal, endocrine, neuropsychiatry, blood tumor and cardiovascular system\n* Subjects with GI tract disease (eg. Crohn's disease, peptic ulcer etc.) or surgery (except appendectomy and herniotomy) influence on administration Investigational new drugs\n* Subjects with hypersensitivity reaction or clinically significant disease in drugs (Aspirin, NSAID anti-inflammatory agents and antibiotics) including Pelubiprofen and Food"}, 'identificationModule': {'nctId': 'NCT01870102', 'briefTitle': 'Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR and Pelubiprofen SR (as a Pelubiprofen 45 mg) Tablet in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Open Label, Cross-over, Phase 1 Trial to Investigate the Pharmacokinetics in Multi-dose and the Food Effect in Single-dose of Pelubiprofen IR and Pelubiprofen SR in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'DW330SR-1002(Ver1.1.)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pelubiprofen IR (Pelubiprofen 30 mg)', 'interventionNames': ['Drug: Pelubiprofen IR (Pelubiprofen 30mg) TID']}, {'type': 'EXPERIMENTAL', 'label': 'Pelubiprofen SR (Pelubiprofen 45 mg)', 'interventionNames': ['Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID']}, {'type': 'OTHER', 'label': 'Pelubiprofen SR (Pelubiprofen 45 mg) fasting condition', 'interventionNames': ['Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID']}, {'type': 'OTHER', 'label': 'Pelubiprofen SR (Pelubiprofen 45 mg) fed condition', 'interventionNames': ['Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID']}], 'interventions': [{'name': 'Pelubiprofen IR (Pelubiprofen 30mg) TID', 'type': 'DRUG', 'armGroupLabels': ['Pelubiprofen IR (Pelubiprofen 30 mg)']}, {'name': 'Pelubiprofen SR (Pelubiprofen 45 mg) BID', 'type': 'DRUG', 'armGroupLabels': ['Pelubiprofen SR (Pelubiprofen 45 mg)', 'Pelubiprofen SR (Pelubiprofen 45 mg) fasting condition', 'Pelubiprofen SR (Pelubiprofen 45 mg) fed condition']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}