Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin

To determine the bioequivalence of new formula of aspirin relative to the established commercial effervescent aspirin when taken orally by healthy adult subjects

• Drug: Acetylsalicylic Acid (Aspirin BAY1019036)
  One tablet of new formula Aspirin under fasting conditions
• Drug: Alka Seltzer Extra Strength
  One effervescent tablet under fasting conditions
• Drug: Aspirin Migraine
  One effervescent tablet under fasting conditions
• Drug: Aspirin Aspro
  One effervescent tablet under fasting conditions

• Experimental: Arm 1
  Intervention: Drug: Acetylsalicylic Acid (Aspirin BAY1019036)
• Active Comparator: Arm 2
  Intervention: Drug: Alka Seltzer Extra Strength
• Active Comparator: Arm 3
  Intervention: Drug: Aspirin Migraine
• Active Comparator: Arm 4
  Intervention: Drug: Aspirin Aspro

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), Nonsteroidal Antiinflammatory Drugs (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 (Over the counter (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)