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
  Purpose

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


Condition Intervention Phase
Arthritis
Drug: PN400
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by POZEN:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of PN 400 under fasting and fed conditions. [ Time Frame: entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: May 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
PN400 administered after meal
Drug: PN400
naproxen/esomeprazole
2
PN400 administered prior to meal
Drug: PN400
naproxen/esomeprazole
3
PN400 administered prior to meal
Drug: PN400
naproxen/esomeprazole
4
PN400 followed by fast
Drug: PN400
naproxen/esomeprazole

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676442

Locations
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
POZEN
  More Information

No publications provided

Responsible Party: Director, Clinical Research, Pozen
ClinicalTrials.gov Identifier: NCT00676442     History of Changes
Other Study ID Numbers: PN400-103
Study First Received: May 8, 2008
Last Updated: September 4, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 15, 2014