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

Phase 1CompletedNCT00676442

POZEN24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Arthritis

Interventions

PN400DRUG

naproxen/esomeprazole

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Austin, Texas, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Time frame: entire study duration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.