[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100239360":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":36,"centralContacts":29,"locations":40,"responsibleParty":53,"collaborators":29,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":29,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":29,"overallStatus":76,"whyStopped":29,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Aspirin dry powder","EXPERIMENTAL","500 mg Acetylsalicylic Acid (ASA) dry powder",[13],"Drug: Aspirin (Acetylsalicylic acid, BAYe4465)",{"label":15,"type":16,"description":17,"interventionNames":18},"Aspirin coated tablet","ACTIVE_COMPARATOR","500 mg ASA coated tablet",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Aspirin effervescent tablet","500 mg ASA effervescent tablet",[13],[24,30,33],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Aspirin (Acetylsalicylic acid, BAYe4465)","One stick pack containing 500 mg acetylsalicylic acid dry powder",[9],null,{"type":25,"name":26,"description":31,"armGroupLabels":32,"otherNames":29},"One tablet containing 500 mg acetylsalicylic acid",[15],{"type":25,"name":26,"description":34,"armGroupLabels":35,"otherNames":29},"One effervescent tablet containing 500 mg acetylsalicylic acid",[20],[37],{"name":38,"affiliation":5,"role":39},"Bayer Study Director","STUDY_DIRECTOR",[41],{"facility":29,"status":29,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":29},"Hackensack","New Jersey","07601","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-74.04347,40.88593,{"lat":51,"lon":50},{"type":54,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100239360","phase-1-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-100239360",false,"NCT02394093","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.","An Open Label Crossover Pharmacokinetic Trial of Aspirin Dry Powder Versus Aspirin Tablets and Aspirin Effervescent Tablets in Healthy Adult Subjects","Icicle","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\u002Fm2, 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\u002For 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\u002Fhemorrhage (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",true,"ALL","18 Years","55 Years",{"count":68,"type":69},30,"ACTUAL","INTERVENTIONAL",[72],"PHASE1","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.",[75],"Pharmacology, Clinical","COMPLETED","2016-09-16",{"date":79,"type":80},"2016-09-19","ESTIMATED",{"date":82,"type":29},"2015-02",{"date":84,"type":69},"2015-03",{"name":5,"class":6},1]