check_circleStudy 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

  • - 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)

  • - 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
February 2008 - March 2008
Phase
Phase 1
Could I Receive a placebo
No
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Arkansas Research Medical Testing, LLCLittle Rock, 72202, United States

Primary Outcome

  • Pharmacokinetics parameters
    date_rangeTime Frame:
    Over 48 Hours
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Assess the safety and tolerability of the investigational product
    date_rangeTime Frame:
    Over 48 Hours
    enhanced_encryption
    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
2

Additional Information

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