Fast & Fed Pharmacokinetic (PK) Study

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Bioavailability

Intervention / Treatment
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* Drug: Naproxen sodium
* Drug: Naproxen sodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Drug: Naproxen sodium<br>* Administered under fasting condition<br>|
| Other: Arm 2<br> | Drug: Naproxen sodium<br>* Administered under fed condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters |  | Over 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the tolerability of the investigational product. |  | Over 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Naproxen Sodium