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Pharmacokinetic Study Comparing Aspirin and Aspirin Granules

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ClinicalTrials.gov Identifier: NCT01072604
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

February 19, 2010
February 22, 2010
April 21, 2014
July 2009
August 2009   (Final data collection date for primary outcome measure)
Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT01072604 on ClinicalTrials.gov Archive Site
  • To assess safety and tolerability of the new aspirin formula [ Time Frame: 24 hours ]
  • To assess additional pharmacokinetic parameters [ Time Frame: 24 hours ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Study Comparing Aspirin and Aspirin Granules
An Open Label Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Aspirin Tablets and Aspirin Dry Granules in Healthy Adult Subjects
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pharmacokinetics
  • Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
    One oral dose of new formula Aspirin Prototype 1 under fasting conditions
  • Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
    One oral dose of new formula Aspirin Prototype 2 under fasting conditions
  • Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
    One oral dose of Aspirin Plain Tablet under fasting conditions
  • Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
    One oral dose of Aspirin Dry Granules under fasting conditions
  • Experimental: Arm 1
    Intervention: Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
  • Experimental: Arm 2
    Intervention: Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
  • Active Comparator: Arm 3
    Intervention: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
  • Active Comparator: Arm 4
    Intervention: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
August 2009
August 2009   (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), 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)
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01072604
14558
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2014

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