check_circleStudy Completed

Pain

Naproxen Sodium ER Pharmacokinetic Study

Trial purpose

To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years

Trial summary

Enrollment Goal
32
Trial Dates
November 2008 - November 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
PPD DevelopmentAustin, 78744, United States

Primary Outcome

  • Pharmacokinetic (PK) Profile of an extended release tablet of Naproxen Sodium under fed conditions
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Assess the safety and tolerability of an extended release tablet of Naproxen Sodium
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

An open label, randomised 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 under fed conditions.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2