ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00676442
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : September 5, 2008
Sponsor:
Information provided by:
POZEN

Brief Summary:
We will evaluate the effect of food on the bioavailability of the components of PN400

Condition or disease Intervention/treatment Phase
Arthritis Drug: PN400 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : May 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676442


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

Responsible Party: Director, Clinical Research, Pozen
ClinicalTrials.gov Identifier: NCT00676442     History of Changes
Other Study ID Numbers: PN400-103
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Esomeprazole
Naproxen
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors