check_circleStudy Completed

Pain

Bayer Identifier:

12656

ClinicalTrials.gov Identifier:

NCT02549469

EudraCT Number:

Not Available

EU CT Number:

Not Available
Bioequivalence of single dose extended release naproxen sodium (660 mg) tablet versus naproxen sodium (220 mg) tablet three times daily

Trial purpose

Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years
  • - 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.
  • - 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).

Trial summary

Enrollment Goal
32
Trial Dates
March 2007 - May 2007
Phase
Phase 1
Could I Receive a placebo
No
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteer
Yes

Primary Outcome

  • Cmax (maximum plasma concentration) for naproxen sodium
    date_rangeTime Frame:
    Days 0, 1, 2, and 3
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    Safety Issue:
    No
  • AUC0-24 (partial area under the curve ) for naproxen sodium
    date_rangeTime Frame:
    Days 0, 1, 2, and 3
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    Safety Issue:
    No
  • AUC0-t (areas under the curve ) for naproxen sodium
    date_rangeTime Frame:
    Days 0, 1, 2, and 3
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    Safety Issue:
    No
  • AUC0-∞ (area under the curve) for naproxen sodium
    date_rangeTime Frame:
    Days 0, 1, 2, and 3
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    Safety Issue:
    No
  • Tmax (The first time point where Cmax is reached) for naproxen sodium
    date_rangeTime Frame:
    Days 0, 1, 2, and 3
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    Safety Issue:
    No
  • AUC0-8 (partial area under the curve) for naproxen sodium
    date_rangeTime Frame:
    Days 0, 1, 2, and 3
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    Safety Issue:
    No
  • AUC8-16 (partial area under the curve ) for naproxen sodium
    date_rangeTime Frame:
    Days 0, 1, 2, and 3
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    Safety Issue:
    No
  • AUC16-24 (partial area under the curve) for naproxen sodium
    date_rangeTime Frame:
    Days 0, 1, 2, and 3
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    Safety Issue:
    No
  • λz (terminal elimination rate constant)
    date_rangeTime Frame:
    Days 0, 1, 2, and 3
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    Safety Issue:
    No
  • t1/2 (terminal half life)
    date_rangeTime Frame:
    Days 0, 1, 2, and 3
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    Safety Issue:
    No

Secondary Outcome

  • Adverse events (AEs) collection
    date_rangeTime Frame:
    up to 50 days
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    Safety Issue:
    Yes
  • Serious adverse events (SAEs) collection
    date_rangeTime Frame:
    up to 50 days
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    Safety Issue:
    Yes
  • Vital signs: sitting blood pressure
    date_rangeTime Frame:
    up to 50 days
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    Safety Issue:
    Yes
  • Vital signs: repiratory rate
    date_rangeTime Frame:
    up to 50 days
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    Safety Issue:
    Yes
  • Vital signs : pulse rate
    date_rangeTime Frame:
    up to 50 days
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    Safety Issue:
    Yes
  • Clinical Laboratory data
    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).
    date_rangeTime Frame:
    up to 50 days
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    Safety Issue:
    Yes
  • Physical examination findings
    Brief physical examination, including height, weight and BMI, was performed at the Screening Visit and at EOS
    date_rangeTime Frame:
    up to 50 days
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    Safety Issue:
    Yes

Trial design

A Pilot Four-Way Crossover Bioequivalence Trial of Sustained Release Forms of Naproxen Versus Aleve Tablets in Healthy Adult Subjects in a Fasted State
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
4

Additional Information

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