Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01081353
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):

March 4, 2010
March 5, 2010
June 26, 2014
February 2010
March 2010   (Final data collection date for primary outcome measure)
Bioavailability of new formulation aspirin versus marketed effervescent tablets (500mg aspirin) [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT01081353 on Archive Site
Adverse event collection [ Time Frame: 24 hours ]
Same as current
Not Provided
Not Provided
Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin
An Open Label 4-Way Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Effervescent Aspirin in Healthy Adult Subjects
To determine the bioequivalence of new formula of aspirin relative to the established commercial effervescent aspirin when taken orally by healthy adult subjects
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2010
March 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Study Director: Bayer Study Director Bayer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP