Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00665743
First received: April 23, 2008
Last updated: June 9, 2008
Last verified: June 2008

April 23, 2008
June 9, 2008
March 2008
June 2008   (final data collection date for primary outcome measure)
To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations [ Time Frame: 72-hour PK ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00665743 on ClinicalTrials.gov Archive Site
To evaluate the safety of the 3 treatments [ Time Frame: entire study duration ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations
An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volunteers

We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Arthritis
  • Drug: PN400
    naproxen 500 mg /esomeprazole 20 mg
  • Drug: naproxen
    naproxen 500 mg tablet
  • Drug: naproxen
    naproxen 500 mg
  • Experimental: A
    PN400 (naproxen/esomeprazole)
    Intervention: Drug: PN400
  • Active Comparator: B
    naproxen 500 mg
    Intervention: Drug: naproxen
  • Active Comparator: C
    naproxen 500 mg
    Intervention: Drug: naproxen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

  • Standard exclusion criteria for a study of this nature
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00665743
PN400-102
No
David Taylor, Pozen
POZEN
Not Provided
Not Provided
POZEN
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP