Pharmacokinetic Study Comparing Aspirin and Aspirin Granules

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Aspirin

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), 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)