check_circleStudy Completed

Bioavailability

Fast & Fed Pharmacokinetic (PK) Study

Trial purpose

The purpose of this study is to provide information on how well an extended release formulation (a medication that is released and absorbed over a longer period of time than a regular release formulation of the medication) of naproxen sodium is absorbed into the bloodstream after eating a high calorie breakfast and also after fasting (not eating for 14 hours).

Key Participants Requirements

Sex

Both

Age

18 - 55 Years

Trial summary

Enrollment Goal
32
Trial Dates
January 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

  • PK parameters
    date_rangeTime Frame:
    Over 48 hours
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Assess the 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 Study to Determine the Bioavailability of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet Under Fasting and Fed Conditions
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2