Pain
Conditions
Brief summary
To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.
Interventions
Extented release Naproxen sodium (660mg) administered once a day
DRUGCommercial Naproxen (Aleve, BAYH6689)
Immediate release Commercial Aleve (220mg) administered in a two ( 440 mg) plus one (220mg) dosing regime, 660 mg daily
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) Profile of an extended release tablet of Naproxen Sodium under fed conditions | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assess the safety and tolerability of an extended release tablet of Naproxen Sodium | 4 weeks |
Countries
United States
Outcome results
None listed