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

NCT ID: NCT02549469

Last Updated: 2015-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2007-05-31

Brief Summary

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Naproxen sodium extended release 660 mg, 20% HPMC

Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve (Naproxen sodium) 220 mg tablet

Group Type: EXPERIMENTAL

Naproxen Sodium ER (BAY117031), 20% HPMC

Intervention Type: DRUG

1 tablet 660 mg administered orally once daily

Naproxen sodium extended release 660 mg, 30% HPMC

Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet

Group Type: EXPERIMENTAL

Naproxen Sodium ER (BAY117031), 30% HPMC

Intervention Type: DRUG

1 tablet 660 mg administered orally once daily

Naproxen sodium extended release 660 mg, 40% HPMC

Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet

Group Type: EXPERIMENTAL

Naproxen Sodium ER (BAY117031), 40% HPMC

Intervention Type: DRUG

1 tablet 660 mg administered orally once daily

Naproxen sodium 220 mg

Bioequivalence in healthy adult subjects in a fasted state

Group Type: ACTIVE_COMPARATOR

Aleve (Naproxen Sodium, BAY117031)

Intervention Type: DRUG

1 tablet 220 mg administered orally three times daily

Interventions

Naproxen Sodium ER (BAY117031), 20% HPMC

1 tablet 660 mg administered orally once daily

Intervention Type: DRUG

Naproxen Sodium ER (BAY117031), 30% HPMC

1 tablet 660 mg administered orally once daily

Intervention Type: DRUG

Naproxen Sodium ER (BAY117031), 40% HPMC

1 tablet 660 mg administered orally once daily

Intervention Type: DRUG

Aleve (Naproxen Sodium, BAY117031)

1 tablet 220 mg administered orally three times daily

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Other Identifiers

12656

Identifier Type: -

Identifier Source: org_study_id