- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00692016
Fast & Fed Pharmacokinetic (PK) Study (Keifer)
May 1, 2013 updated by: Bayer
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Arm 1
|
Administered under fasting condition
Administered under fed condition
|
OTHER: Arm 2
|
Administered under fasting condition
Administered under fed condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK parameters
Time Frame: Over 48 hours
|
Over 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess the tolerability of the investigational product.
Time Frame: Over 48 hours
|
Over 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ACTUAL)
February 1, 2008
Study Completion (ACTUAL)
March 1, 2008
Study Registration Dates
First Submitted
June 5, 2008
First Submitted That Met QC Criteria
June 5, 2008
First Posted (ESTIMATE)
June 6, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 1, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Gout Suppressants
- Naproxen
Other Study ID Numbers
- 13080
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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