Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01081353
First received: March 4, 2010
Last updated: July 2, 2013
Last verified: July 2013

March 4, 2010
July 2, 2013
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01081353 on ClinicalTrials.gov Archive Site
Adverse event collection [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Pharmacokinetics
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
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)
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01081353
14961
Yes
Head Clinical and Medical Affairs, Bayer HealthCare, Consumer Care
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2013

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