Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

This study has been completed.

First Received: June 4, 2008 Last Updated: September 4, 2008 History of Changes

Sponsor:	POZEN
Information provided by:	POZEN
ClinicalTrials.gov Identifier:	NCT00692055

Purpose

We will evaluate the bioavailability of naproxen 375 mg in two formulations

Condition	Intervention	Phase
Arthritis	Drug: PN400 Drug: Naproxen	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study
Official Title:	Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

Resource links provided by NLM:

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by POZEN:

Primary Outcome Measures:

To assess and compare the pharmacokinetics bioavailability of a single oral dose of naproxen administered in two formulations [ Time Frame: 72-hour PK ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety of the two treatments [ Time Frame: entire study duration ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	June 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PN400	Drug: PN400 naproxen 375 mg / esomeprazole 20 mg
2: Active Comparator naproxen 375 mg	Drug: Naproxen naproxen 375 mg

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or non-pregnant female subjects between 18-55 years as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

Standard exclusion criteria for a study of this nature

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692055

Locations

United States, Texas

Austin, Texas, United States

Sponsors and Collaborators

POZEN

More Information

No publications provided

Responsible Party:	POZEN ( David Taylor )
Study ID Numbers:	PN400-105
Study First Received:	June 4, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00692055 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
Molecular Mechanisms of Pharmacological Action
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Gout Suppressants
Pharmacologic Actions
Musculoskeletal Diseases

Analgesics, Non-Narcotic
Sensory System Agents
Arthritis
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010