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

Phase 1

Completed

• Conditions: Arthritis
• Interventions: Drug: PN400

• Registration Number: NCT00676442
• Lead Sponsor: POZEN

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-13
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-04
• Last Update Posted: 2008-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3	PN400	PN400 administered prior to meal
1	PN400	PN400 administered after meal
2	PN400	PN400 administered prior to meal
4	PN400	PN400 followed by fast

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of PN 400 under fasting and fed conditions.	entire study duration