Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-02 @ 3:39 PM
Study NCT ID:
NCT02549469
Status:
COMPLETED
Last Update Posted:
2015-09-15
First Post:
2015-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-11', 'studyFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2015-09-11', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (maximum plasma concentration) for naproxen sodium', 'timeFrame': 'Days 0, 1, 2, and 3'}, {'measure': 'AUC0-24 (partial area under the curve ) for naproxen sodium', 'timeFrame': 'Days 0, 1, 2, and 3'}, {'measure': 'AUC0-t (areas under the curve ) for naproxen sodium', 'timeFrame': 'Days 0, 1, 2, and 3'}, {'measure': 'AUC0-∞ (area under the curve) for naproxen sodium', 'timeFrame': 'Days 0, 1, 2, and 3'}, {'measure': 'Tmax (The first time point where Cmax is reached) for naproxen sodium', 'timeFrame': 'Days 0, 1, 2, and 3'}, {'measure': 'AUC0-8 (partial area under the curve) for naproxen sodium', 'timeFrame': 'Days 0, 1, 2, and 3'}, {'measure': 'AUC8-16 (partial area under the curve ) for naproxen sodium', 'timeFrame': 'Days 0, 1, 2, and 3'}, {'measure': 'AUC16-24 (partial area under the curve) for naproxen sodium', 'timeFrame': 'Days 0, 1, 2, and 3'}, {'measure': 'λz (terminal elimination rate constant)', 'timeFrame': 'Days 0, 1, 2, and 3'}, {'measure': 't1/2 (terminal half life)', 'timeFrame': 'Days 0, 1, 2, and 3'}], 'secondaryOutcomes': [{'measure': 'Adverse events (AEs) collection', 'timeFrame': 'up to 50 days'}, {'measure': 'Serious adverse events (SAEs) collection', 'timeFrame': 'up to 50 days'}, {'measure': 'Vital signs: sitting blood pressure', 'timeFrame': 'up to 50 days'}, {'measure': 'Vital signs: repiratory rate', 'timeFrame': 'up to 50 days'}, {'measure': 'Vital signs : pulse rate', 'timeFrame': 'up to 50 days'}, {'measure': 'Clinical Laboratory data', 'timeFrame': 'up to 50 days', 'description': 'Blood and urine samples were collected according to standard medical guidelines at the Screening Visit. In addition, hematology and chemistry were obtained at the end of the study (EOS).'}, {'measure': 'Physical examination findings', 'timeFrame': 'up to 50 days', 'description': 'Brief physical examination, including height, weight and BMI, was performed at the Screening Visit and at EOS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy ambulatory male and female subjects 18 to 55 years of age, inclusive\n* Body Mass Index (BMI) of approximately 18.0 to 30.0 kg/m2, and a total body weight \\>50 kg (110 lbs)\n* Results of screening and clinical laboratory tests are within normal limits 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, intramuscular injection or double-barrier and have a negative pregnancy test at Screening and on Day 0 of each treatment period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.\n* Provide a personally signed and dated informed consent prior to inclusion in the trial indicating that the subject has been informed of all pertinent aspects of the trial.\n\nExclusion Criteria:\n\n* History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products\n* History of gastrointestinal bleeding or perforation, including bleeding related to previous NSAID therapy. Active, or history of recurrent 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\n* Loss of blood in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis, or injury)\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)\n* Positive alcohol or drug screen at Screening or on Day 0 of Treatment Periods 1 or 2\n* Females who are pregnant or lactating\n* Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (eg, nicotine patch, nicotine gum).'}, 'identificationModule': {'nctId': 'NCT02549469', 'briefTitle': 'Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Pilot Four-Way Crossover Bioequivalence Trial of Sustained Release Forms of Naproxen Versus Aleve Tablets in Healthy Adult Subjects in a Fasted State', 'orgStudyIdInfo': {'id': '12656'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naproxen sodium extended release 660 mg, 20% HPMC', 'description': 'Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve (Naproxen sodium) 220 mg tablet', 'interventionNames': ['Drug: Naproxen Sodium ER (BAY117031), 20% HPMC']}, {'type': 'EXPERIMENTAL', 'label': 'Naproxen sodium extended release 660 mg, 30% HPMC', 'description': 'Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet', 'interventionNames': ['Drug: Naproxen Sodium ER (BAY117031), 30% HPMC']}, {'type': 'EXPERIMENTAL', 'label': 'Naproxen sodium extended release 660 mg, 40% HPMC', 'description': 'Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet', 'interventionNames': ['Drug: Naproxen Sodium ER (BAY117031), 40% HPMC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naproxen sodium 220 mg', 'description': 'Bioequivalence in healthy adult subjects in a fasted state', 'interventionNames': ['Drug: Aleve (Naproxen Sodium, BAY117031)']}], 'interventions': [{'name': 'Naproxen Sodium ER (BAY117031), 20% HPMC', 'type': 'DRUG', 'description': '1 tablet 660 mg administered orally once daily', 'armGroupLabels': ['Naproxen sodium extended release 660 mg, 20% HPMC']}, {'name': 'Naproxen Sodium ER (BAY117031), 30% HPMC', 'type': 'DRUG', 'description': '1 tablet 660 mg administered orally once daily', 'armGroupLabels': ['Naproxen sodium extended release 660 mg, 30% HPMC']}, {'name': 'Naproxen Sodium ER (BAY117031), 40% HPMC', 'type': 'DRUG', 'description': '1 tablet 660 mg administered orally once daily', 'armGroupLabels': ['Naproxen sodium extended release 660 mg, 40% HPMC']}, {'name': 'Aleve (Naproxen Sodium, BAY117031)', 'type': 'DRUG', 'description': '1 tablet 220 mg administered orally three times daily', 'armGroupLabels': ['Naproxen sodium 220 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}