Trial Condition(s):

Healthy

Single/Multiple Dose Bioavailability Trial

Bayer Identifier:

13106

ClinicalTrials.gov Identifier:

NCT00751556

EudraCT Number:

Not Available

Study Completed

Trial Purpose

To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660 mg relative to the established commercial Aleve 220 mg tablet following single dose administration and at steady-state following multiple dose administration for 4 days.

Inclusion Criteria
- Healthy, ambulatory, male and female   volunteers between 18 - 55 years of age with    BMI of approximately 18 to 30 kg/m2, and total   body weight >50 kg (110Ibs)
Exclusion Criteria
- History of hypersensitive 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 Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy Active, or history of current 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

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

Arkansas Research Medical Testing, LLC

Little Rock, United States, 72202

Status
Completed
 

Trial Design