Study Completed

Healthy

Bayer Identifier:

13106

ClinicalTrials.gov Identifier:

NCT00751556

EudraCT Number:

Not Available

EU CT Number:

Not Available

Single/Multiple Dose Bioavailability Trial

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.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years

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

Trial Dates

February 2008 - March 2008

Phase

Phase 1

Could I Receive a placebo

Products

Aleve (Naproxen Sodium ER, BAY117031)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Arkansas Research Medical Testing, LLC	Little Rock, 72202, United States

Primary Outcome

Pharmacokinetics parameters
Time Frame:
Over 48 Hours
Safety Issue:
no

Secondary Outcome

Assess the safety and tolerability of the investigational product
Time Frame:
Over 48 Hours
Safety Issue:
yes

Trial design

An Open Label, Randomized, Two-Way Crossover Trial to Determine the Pharmacokinetic Profile of an Extended Release Naproxen Sodium Tablet Relative to Aleve Tablets Following Single and Multiple Dose Administration in Healthy Adult Subjects

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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