Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-20 @ 11:24 AM
Study NCT ID:
NCT01072604
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2010-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study Comparing Aspirin and Aspirin Granules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-18', 'studyFirstSubmitDate': '2010-02-19', 'studyFirstSubmitQcDate': '2010-02-19', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'To assess safety and tolerability of the new aspirin formula', 'timeFrame': '24 hours'}, {'measure': 'To assess additional pharmacokinetic parameters', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aspirin', 'Acetylsalicylic Acid'], 'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'To determine the bioequivalence of new formula of aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects between 18 to 55 years of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \\>50 kg (110 lbs)\n* Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor\n* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy\n* Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol\n\nExclusion Criteria:\n\n* History of hypersensitivity to aspirin (ASA), NSAIDs, acetaminophen and similar pharmacological agents or components of the products\n* Eighteen to twenty year olds with a viral infection, with or without fever, at the time of dosing\n* Syndromes of asthma, rhinitis or nasal polyps\n* Females who are pregnant or lactating\n* Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment\n* Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)'}, 'identificationModule': {'nctId': 'NCT01072604', 'briefTitle': 'Pharmacokinetic Study Comparing Aspirin and Aspirin Granules', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open Label Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Aspirin Tablets and Aspirin Dry Granules in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '14558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Acetylsalicylic acid (Aspirin, BAY1019036)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: Acetylsalicylic acid (Aspirin, BAY1019036)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3', 'interventionNames': ['Drug: Acetylsalicylic acid (Aspirin, BAYE4465)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4', 'interventionNames': ['Drug: Acetylsalicylic acid (Aspirin, BAYE4465)']}], 'interventions': [{'name': 'Acetylsalicylic acid (Aspirin, BAY1019036)', 'type': 'DRUG', 'description': 'One oral dose of new formula Aspirin Prototype 1 under fasting conditions', 'armGroupLabels': ['Arm 1']}, {'name': 'Acetylsalicylic acid (Aspirin, BAY1019036)', 'type': 'DRUG', 'description': 'One oral dose of new formula Aspirin Prototype 2 under fasting conditions', 'armGroupLabels': ['Arm 2']}, {'name': 'Acetylsalicylic acid (Aspirin, BAYE4465)', 'type': 'DRUG', 'description': 'One oral dose of Aspirin Plain Tablet under fasting conditions', 'armGroupLabels': ['Arm 3']}, {'name': 'Acetylsalicylic acid (Aspirin, BAYE4465)', 'type': 'DRUG', 'description': 'One oral dose of Aspirin Dry Granules under fasting conditions', 'armGroupLabels': ['Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}