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

NCT02549469 | Completed Phase 1

• 1 other identifier: 12656
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (10)

• Cmax (maximum plasma concentration) for naproxen sodium

  Days 0, 1, 2, and 3

• AUC0-24 (partial area under the curve ) for naproxen sodium

  Days 0, 1, 2, and 3

• AUC0-t (areas under the curve ) for naproxen sodium

  Days 0, 1, 2, and 3

• AUC0-∞ (area 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

• AUC0-8 (partial 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

• 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

• t1/2 (terminal half life)

  Days 0, 1, 2, and 3

Secondary Outcomes (7)

• Adverse events (AEs) collection

  up to 50 days

• Serious adverse events (SAEs) collection

  up to 50 days

• Vital signs: sitting blood pressure

  up to 50 days

• Vital signs: repiratory rate

  up to 50 days

• Vital signs : pulse rate

  up to 50 days

Study Arms (4)

Naproxen sodium extended release 660 mg, 20% HPMC

EXPERIMENTAL

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

Drug: Naproxen Sodium ER (BAY117031), 20% HPMC

Naproxen sodium extended release 660 mg, 30% HPMC

EXPERIMENTAL

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

Drug: Naproxen Sodium ER (BAY117031), 30% HPMC

Naproxen sodium extended release 660 mg, 40% HPMC

EXPERIMENTAL

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

Drug: Naproxen Sodium ER (BAY117031), 40% HPMC

Naproxen sodium 220 mg

ACTIVE COMPARATOR

Bioequivalence in healthy adult subjects in a fasted state

Drug: Aleve (Naproxen Sodium, BAY117031)

Interventions

Naproxen Sodium ER (BAY117031), 20% HPMC DRUG

1 tablet 660 mg administered orally once daily

Naproxen sodium extended release 660 mg, 20% HPMC

Naproxen Sodium ER (BAY117031), 30% HPMC DRUG

1 tablet 660 mg administered orally once daily

Naproxen sodium extended release 660 mg, 30% HPMC

Naproxen Sodium ER (BAY117031), 40% HPMC DRUG

1 tablet 660 mg administered orally once daily

Naproxen sodium extended release 660 mg, 40% HPMC

Aleve (Naproxen Sodium, BAY117031) DRUG

1 tablet 220 mg administered orally three times daily

Naproxen sodium 220 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Pain

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: September 15, 2015
• Study Start: March 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: September 15, 2015

Record last verified: 2015-09