Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-03 @ 4:17 AM
Study NCT ID:
NCT02394093
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2015-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Bioavailability of a Single Oral Dose of the Acetylsalicylic Acid Containing Dry Powder 500 mg in Comparison to the Bioavailability of a Single Oral Dose of Aspirin Tablets and Aspirin Effervescent Tablets in Healthy Adults.
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': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-16', 'studyFirstSubmitDate': '2015-03-14', 'studyFirstSubmitQcDate': '2015-03-14', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of Acetylsalicylic Acid (ASA) characterized by AUC0-t', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.'}, {'measure': 'Plasma concentration of Acetylsalicylic Acid (ASA) characterized by AUC0-∞', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.', 'description': 'AUC0-∞ : AUC from zero to infinity after single dose.'}, {'measure': 'Plasma concentration of Acetylsalicylic Acid (ASA) characterized by Cmax', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.', 'description': 'Cmax: maximum drug concentration in plasma after single dose administration'}, {'measure': 'Plasma concentration of Acetylsalicylic Acid (ASA) characterized by tmax', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.', 'description': 'tmax: time to reach maximum drug concentration in plasma after single (first) dose'}, {'measure': 'Plasma concentration of Acetylsalicylic Acid (ASA) characterized by λz (Kel)', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose', 'description': 'λz (Kel) : Apparent terminal rate constant, calculated from the slope of a log-linear regression of the unweighted data considering the last concentration-time points \\> LLOQ'}, {'measure': 'Plasma concentration of Acetylsalicylic Acid (ASA) characterized by t1/2', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.'}, {'measure': 'Plasma concentration of Acetylsalicylic Acid (ASA) characterized by t lag', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.', 'description': 't lag : Lag-time (time delay between drug administration and first observed concentration above LLOQ (Lower limit of quantification)'}, {'measure': 'Plasma concentration of Acetylsalicylic Acid (ASA) characterized by Cmax/AUC0-∞', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.'}, {'measure': 'Plasma concentration of Acetyl salicylic Acid (ASA) characterized by MRT', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.', 'description': 'MRT :Mean residence time (for extravascular and iv bolus administration)'}, {'measure': 'Plasma concentration of Salicylic Acid (SA) characterized by AUC0-t', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.'}, {'measure': 'Plasma concentration of Salicylic Acid (SA) characterized by AUC0-∞', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.', 'description': 'AUC0-∞ : AUC from zero to infinity after single dose'}, {'measure': 'Plasma concentration of Salicylic Acid (SA) characterized by Cmax', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.', 'description': 'Cmax: maximum drug concentration in plasma after single dose administration'}, {'measure': 'Plasma concentration of Salicylic Acid (SA) characterized by tmax', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.', 'description': 'tmax: time to reach maximum drug concentration in plasma after single (first) dose'}, {'measure': 'Plasma concentration of Salicylic Acid (SA) characterized by λz (Kel)', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.', 'description': 'λz (Kel) : Apparent terminal rate constant, calculated from the slope of a log-linear regression of the unweighted data considering the last concentration-time points \\> LLOQ'}, {'measure': 'Plasma concentration of Salicylic Acid (SA) characterized by t1/2', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.'}, {'measure': 'Plasma concentration of Salicylic Acid (SA) characterized by t lag', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.', 'description': 't lag : Lag-time (time delay between drug administration and first observed concentration above LLOQ'}, {'measure': 'Plasma concentration of Salicylic Acid (SA) characterized by Cmax/AUC0-∞', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.'}, {'measure': 'Plasma concentration of Salicylic Acid (SA) characterized by MRT', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.', 'description': 'MRT :Mean residence time (for extravascular and iv bolus administration)'}, {'measure': 'Plasma concentration of Acetylsalicylic Acid (ASA) characterized by AUC0-t /AUC0-∞', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.'}, {'measure': 'Plasma concentration of Salicylic Acid (SA) characterized by AUC0-t /AUC0-∞', 'timeFrame': 'baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Adverse Events as measure of safety and tolerability', 'timeFrame': 'Up to 5 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pharmacology, Clinical']}, 'descriptionModule': {'briefSummary': 'To evaluate the bioavailability of a single oral dose of the Acetylsalicylic Acid containing dry powder 500 mg in comparison to the bioavailability of a single oral dose of aspirin tablets and aspirin effervescent tablets in healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy ,male and female subjects 18 to 55 years of age, inclusive\n* 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 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\nExclusion Criteria:\n\n* History of hypersensitivity to acetylsalicylic acid (ASA), naproxen sodium, acetaminophen, other non-steroidal anti-inflammatory drugs (NSAIDs), 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 or any other NSAID (OTC or prescription) seven days prior to dosing or during the Treatment Periods, other than study product\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 disease, or malignancies\n* Positive alcohol or drug screen at Screening or on Day 0 of Treatment Periods 1,2 and 3\n* Females who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT02394093', 'acronym': 'Icicle', 'briefTitle': 'To Evaluate the Bioavailability of a Single Oral Dose of the Acetylsalicylic Acid Containing Dry Powder 500 mg in Comparison to the Bioavailability of a Single Oral Dose of Aspirin Tablets and Aspirin Effervescent Tablets in Healthy Adults.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open Label Crossover Pharmacokinetic Trial of Aspirin Dry Powder Versus Aspirin Tablets and Aspirin Effervescent Tablets in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '17494'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aspirin dry powder', 'description': '500 mg Acetylsalicylic Acid (ASA) dry powder', 'interventionNames': ['Drug: Aspirin (Acetylsalicylic acid, BAYe4465)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin coated tablet', 'description': '500 mg ASA coated tablet', 'interventionNames': ['Drug: Aspirin (Acetylsalicylic acid, BAYe4465)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin effervescent tablet', 'description': '500 mg ASA effervescent tablet', 'interventionNames': ['Drug: Aspirin (Acetylsalicylic acid, BAYe4465)']}], 'interventions': [{'name': 'Aspirin (Acetylsalicylic acid, BAYe4465)', 'type': 'DRUG', 'description': 'One stick pack containing 500 mg acetylsalicylic acid dry powder', 'armGroupLabels': ['Aspirin dry powder']}, {'name': 'Aspirin (Acetylsalicylic acid, BAYe4465)', 'type': 'DRUG', 'description': 'One tablet containing 500 mg acetylsalicylic acid', 'armGroupLabels': ['Aspirin coated tablet']}, {'name': 'Aspirin (Acetylsalicylic acid, BAYe4465)', 'type': 'DRUG', 'description': 'One effervescent tablet containing 500 mg acetylsalicylic acid', 'armGroupLabels': ['Aspirin effervescent tablet']}]}, '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'}}}}