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

NCT00676442 | Completed Phase 1

• 1 other identifier: PN400-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthritis

Outcome Measures

Primary Outcomes (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.

  72-hours

Secondary Outcomes (1)

• To assess the safety and tolerability of PN 400 under fasting and fed conditions.

  entire study duration

Study Arms (4)

1

OTHER

PN400 administered after meal

Drug: PN400

2

OTHER

PN400 administered prior to meal

Drug: PN400

3

OTHER

PN400 administered prior to meal

Drug: PN400

4

OTHER

PN400 followed by fast

Drug: PN400

Interventions

PN400 DRUG

naproxen/esomeprazole

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• POZEN: lead

Study Sites (1)

Unknown Facility

Austin, Texas, United States

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 13, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 5, 2008

Record last verified: 2008-09

Locations

US (1)