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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014