Expired Study
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Austin, Texas 78744


Purpose:

To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.


Criteria:

Inclusion Criteria: - Healthy ambulatory, male and female volunteers between 18-55 years of age with a Body Mass Index (BMI) of approximately 18 to 30kg/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 and the 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, NuvaRing, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and Day 0 of 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 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 to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products - History of gastrointestinal bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug (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 diseases or malignancies - Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (Over the counter (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) - Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the trial - Alcoholism or drug abuse within 2 years prior to the Screening Visit - Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit


NCT ID:

NCT00818415


Primary Contact:

Study Director
Bayer Study Director
Bayer


Backup Contact:

N/A


Location Contact:

Austin, Texas 78744
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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