Pharmacokinetic Study Comparing Aspirin and Aspirin Granules

Study Overview
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Brief Summary
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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

Official Title
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An Open Label Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Aspirin Tablets and Aspirin Dry Granules in Healthy Adult Subjects

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
* Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
* Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
* Drug: Acetylsalicylic acid (Aspirin, BAYE4465)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor 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 Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol Exclusion Criteria: History of hypersensitivity to aspirin (ASA), NSAIDs, acetaminophen and similar pharmacological agents or components of the products Eighteen to twenty year olds with a viral infection, with or without fever, at the time of dosing Syndromes of asthma, rhinitis or nasal polyps Females who are pregnant or lactating 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 Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Acetylsalicylic acid (Aspirin, BAY1019036)<br>* One oral dose of new formula Aspirin Prototype 1 under fasting conditions<br>|
| Experimental: Arm 2<br> | Drug: Acetylsalicylic acid (Aspirin, BAY1019036)<br>* One oral dose of new formula Aspirin Prototype 2 under fasting conditions<br>|
| Active Comparator: Arm 3<br> | Drug: Acetylsalicylic acid (Aspirin, BAYE4465)<br>* One oral dose of Aspirin Plain Tablet under fasting conditions<br>|
| Active Comparator: Arm 4<br> | Drug: Acetylsalicylic acid (Aspirin, BAYE4465)<br>* One oral dose of Aspirin Dry Granules under fasting conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety and tolerability of the new aspirin formula |  | 24 hours | 
| To assess additional pharmacokinetic parameters |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspirin, Acetylsalicylic Acid