Naproxen Sodium ER Pharmacokinetic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00818415
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : May 19, 2014
Information provided by (Responsible Party):

December 8, 2008
January 7, 2009
May 19, 2014
November 2008
November 2008   (Final data collection date for primary outcome measure)
Pharmacokinetic (PK) Profile of an extended release tablet of Naproxen Sodium under fed conditions [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT00818415 on Archive Site
Assess the safety and tolerability of an extended release tablet of Naproxen Sodium [ Time Frame: 4 weeks ]
Same as current
Not Provided
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Naproxen Sodium ER Pharmacokinetic Study
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.
To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: Naproxen sodium ER (BAYH6689)
    Extented release Naproxen sodium (660mg) administered once a day
  • Drug: Commercial Naproxen (Aleve, BAYH6689)
    Immediate release Commercial Aleve (220mg) administered in a two ( 440 mg) plus one (220mg) dosing regime, 660 mg daily
  • Experimental: Arm 1
    Intervention: Drug: Naproxen sodium ER (BAYH6689)
  • Active Comparator: Arm 2
    Intervention: Drug: Commercial Naproxen (Aleve, BAYH6689)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2008
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Not Provided
Study Director: Bayer Study Director Bayer
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP