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

Pain Clinical Trial

Official title:

A Pilot Four-Way Crossover Bioequivalence Trial of Sustained Release Forms of Naproxen Versus Aleve Tablets in Healthy Adult Subjects in a Fasted State

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549469
• Other study ID #: 12656
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2015
• Last updated: September 11, 2015
• Start date: March 2007
• Est. completion date: May 2007

Study information

• Verified date: September 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Naproxen Sodium ER (BAY117031), 20% HPMC
1 tablet 660 mg administered orally once daily
• Naproxen Sodium ER (BAY117031), 30% HPMC
1 tablet 660 mg administered orally once daily
• Naproxen Sodium ER (BAY117031), 40% HPMC
1 tablet 660 mg administered orally once daily
• Aleve (Naproxen Sodium, BAY117031)
1 tablet 220 mg administered orally three times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (maximum plasma concentration) for naproxen sodium		Days 0, 1, 2, and 3	No
Primary	AUC0-24 (partial area under the curve ) for naproxen sodium		Days 0, 1, 2, and 3	No
Primary	AUC0-t (areas under the curve ) for naproxen sodium		Days 0, 1, 2, and 3	No
Primary	AUC0-8 (area under the curve) for naproxen sodium		Days 0, 1, 2, and 3	No
Primary	Tmax (The first time point where Cmax is reached) for naproxen sodium		Days 0, 1, 2, and 3	No
Primary	AUC0-8 (partial area under the curve) for naproxen sodium		Days 0, 1, 2, and 3	No
Primary	AUC8-16 (partial area under the curve ) for naproxen sodium		Days 0, 1, 2, and 3	No
Primary	AUC16-24 (partial area under the curve) for naproxen sodium		Days 0, 1, 2, and 3	No
Primary	?z (terminal elimination rate constant)		Days 0, 1, 2, and 3	No
Primary	t1/2 (terminal half life)		Days 0, 1, 2, and 3	No
Secondary	Adverse events (AEs) collection		up to 50 days	Yes
Secondary	Serious adverse events (SAEs) collection		up to 50 days	Yes
Secondary	Vital signs: sitting blood pressure		up to 50 days	Yes
Secondary	Vital signs: repiratory rate		up to 50 days	Yes
Secondary	Vital signs : pulse rate		up to 50 days	Yes
Secondary	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).	up to 50 days	Yes
Secondary	Physical examination findings	Brief physical examination, including height, weight and BMI, was performed at the Screening Visit and at EOS	up to 50 days	Yes

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