Naproxen Sodium ER Pharmacokinetic Study

NCT ID: NCT00818415

Last Updated: 2014-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2008-11-30

Brief Summary

To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.

Conditions

Pain

Study Design

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

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Naproxen sodium ER (BAYH6689)

Intervention Type: DRUG

Extented release Naproxen sodium (660mg) administered once a day

Arm 2

Group Type: ACTIVE_COMPARATOR

Commercial Naproxen (Aleve, BAYH6689)

Intervention Type: DRUG

Immediate release Commercial Aleve (220mg) administered in a two ( 440 mg) plus one (220mg) dosing regime, 660 mg daily

Interventions

Naproxen sodium ER (BAYH6689)

Extented release Naproxen sodium (660mg) administered once a day

Intervention Type: DRUG

Commercial Naproxen (Aleve, BAYH6689)

Immediate release Commercial Aleve (220mg) administered in a two ( 440 mg) plus one (220mg) dosing regime, 660 mg daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy ambulatory, male and female volunteers between 18-55 years of age with a Body Mass Index (BMI) of approximately 18 to 30kg/m2, and a total body weight >50 kg (110 lbs)
• Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the principal Investigator and the 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, NuvaRing, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and Day 0 of each Dosing Period. Female subjects of non childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
• Be willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the protocol
• Provide a personally signed and dated informed consent 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, related to previous nonsteroidal anti-inflammatory drug (NSAID) therapy. Active, or history of recurrent peptic ulcer/ hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies
• Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (Over the counter (OTC) or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
• Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)
• Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the trial
• Alcoholism or drug abuse within 2 years prior to the Screening Visit
• Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit

• 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

Locations

Austin, Texas, United States

Countries

United States

Other Identifiers

13965

Identifier Type: -

Identifier Source: org_study_id