Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations - Full Text View

Sponsored by:	Pozen
Information provided by:	Pozen
ClinicalTrials.gov Identifier:	NCT00665743

Purpose

We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.

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

Drug Information available for: Naproxen Naproxen sodium Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study
Official Title:	An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volunteers

Further study details as provided by Pozen:

Primary Outcome Measures:

To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations [ Time Frame: 72-hour PK ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety of the 3 treatments [ Time Frame: entire study duration ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
A: Experimental PN400 (naproxen/esomeprazole)	Drug: PN400 naproxen 500 mg /esomeprazole 20 mg
B: Active Comparator naproxen 500 mg	Drug: naproxen naproxen 500 mg tablet
C: Active Comparator naproxen 500 mg	Drug: naproxen naproxen 500 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 of age 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: NCT00665743

Locations

United States, Texas

Austin, Texas, United States

Sponsors and Collaborators

Pozen

More Information

Responsible Party:	Pozen ( David Taylor )
Study ID Numbers:	PN400-102
Study First Received:	April 23, 2008
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00665743
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Naproxen
Musculoskeletal Diseases
Joint Diseases

Arthritis
Omeprazole
Healthy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Pharmacologic Actions
Analgesics, Non-Narcotic

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

ClinicalTrials.gov processed this record on January 16, 2009