Naproxen Sodium ER Pharmacokinetic Study

Bayer

Status and phase

Completed

Phase 1

Conditions

Pain

Treatments

Drug: Commercial Naproxen (Aleve, BAYH6689)

Drug: Naproxen sodium ER (BAYH6689)

Study type

Interventional

Funder types

Industry

Identifiers

13965

Details and patient eligibility

About

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

Enrollment

32 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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