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

Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676442
• Other study ID #: PN400-103
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2008
• Last updated: September 4, 2008
• Start date: May 2008
• Est. completion date: June 2008

Study information

• Verified date: September 2008
• Source: POZEN
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis

Intervention

Drug:
• PN400
naproxen/esomeprazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
POZEN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		72-hours	No
Secondary	To assess the safety and tolerability of PN 400 under fasting and fed conditions.		entire study duration	Yes