Naproxen Sodium/ASA Platelet Study
Condition: Hematology
Intervention: Naproxen Sodium (Aleve, BAY117031); Acetylsalicylic Acid (Aspirin, BAYE4465)
Intervention description: Naproxen sodium 220 mg qd or bid; ASA 81 mg qd
Intervention MeSH terms: Aspirin; Naproxen
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory
      effect of a low dose Immediate Release Aspirin (IR ASA) regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, ambulatory, male and female volunteers between 18 - 70 years of age with a
             Body Mass Index (BMI) of approximately 18 to 30 kg/m2, and a total body weight > 50 kg
             (110 lbs)

          -  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
             immediately prior to investigational product administration on Day 1 and Day 6. Female
             subjects of non-childbearing potential must be amenorrheic for at least 2 years or had
             a hysterectomy and/or bilateral oophorectomy

          -  Results of screening and clinical laboratory tests are within normal range or
             considered not clinically significant by the Principal Investigator and the Sponsor

          -  Be willing and able to participate in all scheduled visits, treatment plan, laboratory
             tests and other trial procedures according to the protocol

          -  Provide a personally signed and dated informed consent indicating that the subject has
             been informed of all pertinent aspects of the trial.

        Exclusion Criteria:

          -  History of hypersensitivity or asthma type symptoms with use of aspirin, naproxen
             sodium and similar pharmacological agents or components of the products

          -  Females who are pregnant or lactating

          -  Any disorder of the Aspirin Triad Syndrome (i.e., asthma, rhinitis or nasal polyps),
             or have chronic urticaria

          -  Eighteen to twenty years old with a viral infection, with or without fever within one
             month prior to start of Run-in Period

          -  History of gastrointestinal bleeding or perforation, related to previous NSAID
             therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct
             episodes of proven ulceration or bleeding)

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
             infectious diseases or malignancies

          -  Any abnormal laboratory value or physical finding that according to the Investigator
             that may interfere with the interpretation of the study results or be indicative of an
             underlying disease state

          -  Have taken any medications including NSAIDs (except acceptable forms of birth control)
             within 7 days prior to the start of the Run-in Period or throughout the study, unless
             in the opinion of the Investigator and the Sponsor, the medication will not interfere
             with the study procedures, data integrity, data interpretation or compromise the
             safety of the subject

          -  Have taken antiplatelet or anticoagulant drugs within 30 days prior to start of the
             Run-in Period or during their participation in the study

          -  Have donated blood or blood components within 30 days prior to study entry