check_circleStudy Completed

Pain

Naproxen Sodium ER Pharmacokinetic Study

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 55 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
32
Trial Dates
November 2008 - November 2008
Phase
Phase 1
Could I Receive a placebo
No
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
PPD DevelopmentAustin, 78744, United States

Primary Outcome

  • Pharmacokinetic (PK) Profile of an extended release tablet of Naproxen Sodium under fed conditions
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Assess the safety and tolerability of an extended release tablet of Naproxen Sodium
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

An open label, randomised two way Crossover trial to determine the Pharmacokinetic profile of an extended release Naproxen Sodium tablet relative to Aleve tablets following single and multiple dose administration under fed conditions.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2