Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-01-02 @ 2:19 PM
Study NCT ID:
NCT00599404
Status:
COMPLETED
Last Update Posted:
2008-04-30
First Post:
2008-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-23', 'studyFirstSubmitDate': '2008-01-11', 'studyFirstSubmitQcDate': '2008-01-22', 'lastUpdatePostDateStruct': {'date': '2008-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic profile following dosing with PN400', 'timeFrame': '24-hour PK on Day 1 & Day 10 of each treatment period'}], 'secondaryOutcomes': [{'measure': 'To evaluate the safety of PN400', 'timeFrame': 'Day 1-10 of each treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics study'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400 tablets from the same drug product batch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature\n\nExclusion Criteria:\n\nStandard inclusion criteria for a study of this nature'}, 'identificationModule': {'nctId': 'NCT00599404', 'briefTitle': 'PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400', 'organization': {'class': 'INDUSTRY', 'fullName': 'POZEN'}, 'officialTitle': 'An Open-Label, 2-Period Pharmacokinetic Study to Evaluate the Intra-Subject Variability in Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400 Tablets', 'orgStudyIdInfo': {'id': 'PN400-111'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PN400', 'type': 'DRUG', 'description': '500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'POZEN', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'David Taylor', 'oldOrganization': 'Pozen'}}}}