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Fast & Fed Pharmacokinetic (PK) Study (Keifer)

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ClinicalTrials.gov Identifier: NCT00692016
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : May 3, 2013
Information provided by:

Brief Summary:
The purpose of this study is to provide information on how well an extended release formulation (a medication that is released and absorbed over a longer period of time than a regular release formulation of the medication) of naproxen sodium is absorbed into the bloodstream after eating a high calorie breakfast and also after fasting (not eating for 14 hours).

Condition or disease Intervention/treatment Phase
Bioavailability Drug: Naproxen sodium Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Two-Way Crossover Study to Determine the Bioavailability of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet Under Fasting and Fed Conditions
Study Start Date : January 2008
Primary Completion Date : February 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Arm 1 Drug: Naproxen sodium
Administered under fasting condition
Arm 2 Drug: Naproxen sodium
Administered under fed condition

Primary Outcome Measures :
  1. PK parameters [ Time Frame: Over 48 hours ]

Secondary Outcome Measures :
  1. Assess the tolerability of the investigational product. [ Time Frame: Over 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy, ambulatory, male and female volunteers between 18 to 55 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);
  • 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 nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy

Exclusion Criteria:

  • History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products;
  • Females who are pregnant or lactating;
  • Loss of blood in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);
  • 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 diseases or malignancies;
  • Positive alcohol or drug test;
  • Have taken any medications (except acceptable forms of birth control) within 10 days prior to dosing 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, or compromise the safety of the subject;
  • Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study 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 study;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692016

United States, Arkansas
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier: NCT00692016     History of Changes
Other Study ID Numbers: 13080
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

Keywords provided by Bayer:
Naproxen Sodium

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action