check_circleStudy Completed

Pharmacokinetics

Pharmacokinetics study comparing Naproxen Sodium Extended Release and Naprelan

Trial purpose

To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration for 36 hours under fasted conditions

Key Participants Requirements

Sex

Both

Age

18 - 55 Years

Trial summary

Enrollment Goal
28
Trial Dates
April 2009 - May 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
PPD DevelopmentAustin, 78744, United States

Primary Outcome

  • Pharmacokinetic profile of Naproxen Sodium ER 660 mg compared to Naprelan
    date_rangeTime Frame:
    36 hours
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • To assess safety and tolerability of the extended release naproxen sodium
    date_rangeTime Frame:
    36 hours
    enhanced_encryption
    Safety Issue:
    yes
  • To assess additional pharmacokinetic parameters
    date_rangeTime Frame:
    36 hours
    enhanced_encryption
    Safety Issue:
    yes

Trial design

An Open Label, Randomized, Two-Way Crossover Trial to Compare the Pharmacokinetic Parameters of an Extended- Release Naproxen Sodium Tablet Relative to Naprelan® Tablets Following Single Dose Administration Under Fasted Conditions
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2