Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily

Recruitment & Eligibility

Inclusion Criteria

Healthy ambulatory male and female subjects 18 to 55 years of age, inclusive
Body Mass Index (BMI) of approximately 18.0 to 30.0 kg/m2, and a total body weight >50 kg (110 lbs)
Results of screening and clinical laboratory tests are within normal limits or considered not clinically significant by the Principal Investigator or 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, intramuscular injection or double-barrier and have a negative pregnancy test at Screening and on Day 0 of each treatment period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
Provide a personally signed and dated informed consent prior to inclusion in the trial 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, including bleeding related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
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
Loss of blood in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis, or injury)
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Positive alcohol or drug screen at Screening or on Day 0 of Treatment Periods 1 or 2
Females who are pregnant or lactating
Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (eg, nicotine patch, nicotine gum).

Study & Design

Arm && Interventions

Group	Intervention	Description
Naproxen sodium extended release 660 mg, 40% HPMC	Naproxen Sodium ER (BAY117031), 40% HPMC	Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet
Naproxen sodium 220 mg	Aleve (Naproxen Sodium, BAY117031)	Bioequivalence in healthy adult subjects in a fasted state
Naproxen sodium extended release 660 mg, 20% HPMC	Naproxen Sodium ER (BAY117031), 20% HPMC	Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve (Naproxen sodium) 220 mg tablet
Naproxen sodium extended release 660 mg, 30% HPMC	Naproxen Sodium ER (BAY117031), 30% HPMC	Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet

Primary Outcome Measures

Name	Time	Method
AUC0-24 (partial area under the curve ) for naproxen sodium	Days 0, 1, 2, and 3
AUC0-8 (partial area under the curve) for naproxen sodium	Days 0, 1, 2, and 3
Cmax (maximum plasma concentration) for naproxen sodium	Days 0, 1, 2, and 3
AUC0-∞ (area under the curve) for naproxen sodium	Days 0, 1, 2, and 3
AUC8-16 (partial area under the curve ) for naproxen sodium	Days 0, 1, 2, and 3
t1/2 (terminal half life)	Days 0, 1, 2, and 3
AUC0-t (areas under the curve ) for naproxen sodium	Days 0, 1, 2, and 3
Tmax (The first time point where Cmax is reached) for naproxen sodium	Days 0, 1, 2, and 3
AUC16-24 (partial area under the curve) for naproxen sodium	Days 0, 1, 2, and 3
λz (terminal elimination rate constant)	Days 0, 1, 2, and 3

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs) collection	up to 50 days
Vital signs: repiratory rate	up to 50 days
Vital signs : pulse rate	up to 50 days
Clinical Laboratory data	up to 50 days	Blood and urine samples were collected according to standard medical guidelines at the Screening Visit. In addition, hematology and chemistry were obtained at the end of the study (EOS).
Physical examination findings	up to 50 days	Brief physical examination, including height, weight and BMI, was performed at the Screening Visit and at EOS
Serious adverse events (SAEs) collection	up to 50 days
Vital signs: sitting blood pressure	up to 50 days

Recruitment & Eligibility