Pharmacokinetics
Conditions
Keywords
Aspirin, Acetylsalicylic Acid
Brief summary
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
Interventions
One oral dose of new formula Aspirin Prototype 1 under fasting conditions
One oral dose of Aspirin Plain Tablet under fasting conditions
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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), 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability of the new aspirin formula | 24 hours |
| To assess additional pharmacokinetic parameters | 24 hours |
Countries
United States
Outcome results
None listed