Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT00751556
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2008-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single/Multiple Dose Bioavailability Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-18', 'studyFirstSubmitDate': '2008-09-11', 'studyFirstSubmitQcDate': '2008-09-11', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics parameters', 'timeFrame': 'Over 48 Hours'}], 'secondaryOutcomes': [{'measure': 'Assess the safety and tolerability of the investigational product', 'timeFrame': 'Over 48 Hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Naproxen Sodium', 'Bioavailability'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660 mg relative to the established commercial Aleve 220 mg tablet following single dose administration and at steady-state following multiple dose administration for 4 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, ambulatory, male and female volunteers between 18 - 55 years of age with BMI of approximately 18 to 30 kg/m2, and total body weight \\>50 kg (110Ibs)\n\nExclusion Criteria:\n\n* History of hypersensitive to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products\n* History of gastrointestinal bleeding or perforation related to previous Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy Active, or history of current peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)\n* Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment'}, 'identificationModule': {'nctId': 'NCT00751556', 'briefTitle': 'Single/Multiple Dose Bioavailability Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open Label, Randomized, Two-Way Crossover Trial to Determine the Pharmacokinetic Profile of an Extended Release Naproxen Sodium Tablet Relative to Aleve Tablets Following Single and Multiple Dose Administration in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '13106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Naproxen Sodium 660mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: Commercial Aleve 220 mg']}], 'interventions': [{'name': 'Naproxen Sodium 660mg', 'type': 'DRUG', 'description': 'Extended release Naproxen Sodium (660mg) administered once a day', 'armGroupLabels': ['Arm 1']}, {'name': 'Commercial Aleve 220 mg', 'type': 'DRUG', 'description': 'Immediate release commercial Aleve (220 mg) administered in a 2 (440 mg) plus one (220 mg) dosing schedule, 660 mg total', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}