Pharmacokinetic Study Comparing Aspirin and Aspirin Granules

Bayer

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Acetylsalicylic acid (Aspirin, BAY1019036)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01072604

14558

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

Arm 1

Experimental group

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAY1019036)

Drug: Acetylsalicylic acid (Aspirin, BAY1019036)

Arm 2

Experimental group

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAY1019036)

Drug: Acetylsalicylic acid (Aspirin, BAY1019036)

Arm 3

Active Comparator group

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Arm 4

Active Comparator group

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)