Trial Condition(s):

Pain

Naproxen Sodium ER Pharmacokinetic Study

Bayer Identifier:

13965

ClinicalTrials.gov Identifier:

NCT00818415

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
32
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

PPD Development

Austin, United States, 78744

Status
Completed
 

Trial Design