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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):

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

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: Acetylsalicylic Acid (Aspirin BAY1019036) Drug: Alka Seltzer Extra Strength Drug: Aspirin Migraine Drug: Aspirin Aspro Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label 4-Way Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Effervescent Aspirin in Healthy Adult Subjects
Study Start Date : February 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Arm 1 Drug: Acetylsalicylic Acid (Aspirin BAY1019036)
One tablet of new formula Aspirin under fasting conditions

Active Comparator: Arm 2 Drug: Alka Seltzer Extra Strength
One effervescent tablet under fasting conditions

Active Comparator: Arm 3 Drug: Aspirin Migraine
One effervescent tablet under fasting conditions

Active Comparator: Arm 4 Drug: Aspirin Aspro
One effervescent tablet under fasting conditions

Primary Outcome Measures :
  1. Bioavailability of new formulation aspirin versus marketed effervescent tablets (500mg aspirin) [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Adverse event collection [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01081353

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United States, New Jersey
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT01081353    
Other Study ID Numbers: 14961
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Keywords provided by Bayer:
Acetylsalicylic Acid
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors