Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin
Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetics
Intervention: Acetylsalicylic Acid (Aspirin BAY1019036) (Drug); Alka Seltzer Extra Strength (Drug); Aspirin Migraine (Drug); Aspirin Aspro (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
To determine the bioequivalence of new formula of aspirin relative to the established
commercial effervescent aspirin when taken orally by healthy adult subjects
Clinical Details
Official title: An Open Label 4-Way Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Effervescent Aspirin in Healthy Adult Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioavailability of new formulation aspirin versus marketed effervescent tablets (500mg aspirin)
Secondary outcome: Adverse event collection
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Hackensack, New Jersey 07601, United States
Additional Information
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Starting date: February 2010
Last updated: June 25, 2014
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