Trial Condition(s):

Hematology

Naproxen Sodium/ASA Platelet Study (Kontakt)

Bayer Identifier:

15525

ClinicalTrials.gov Identifier:

NCT02229461

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
117
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Austin, United States, 78744

Status
Completed
 

Trial Design