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Study Evaluating the Effect of Food on the Bioavailability of PN400 Components

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00676442
First received: May 8, 2008
Last updated: September 4, 2008
Last verified: September 2008

May 8, 2008
September 4, 2008
May 2008
June 2008   (final data collection date for primary outcome measure)
To determine the effects of food eaten at different times on the bioavailability of the components of PN400 following a single oral dose in healthy subjects. [ Time Frame: 72-hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00676442 on ClinicalTrials.gov Archive Site
To assess the safety and tolerability of PN 400 under fasting and fed conditions. [ Time Frame: entire study duration ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Effect of Food on the Bioavailability of PN400 Components
An Open-Label, Randomized, Four-Way Crossover Study to Evaluate the Effect of Food on the Bioavailability of Naproxen and Esomeprazole From a PN 400 Tablet in Healthy Subjects

We will evaluate the effect of food on the bioavailability of the components of PN400

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Arthritis
Drug: PN400
naproxen/esomeprazole
  • 1
    PN400 administered after meal
    Intervention: Drug: PN400
  • 2
    PN400 administered prior to meal
    Intervention: Drug: PN400
  • 3
    PN400 administered prior to meal
    Intervention: Drug: PN400
  • 4
    PN400 followed by fast
    Intervention: Drug: PN400
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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 old 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
 
NCT00676442
PN400-103
No
Director, Clinical Research, Pozen
POZEN
Not Provided
Not Provided
POZEN
September 2008

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