A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels - Full Text View

Purpose

A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.

Condition	Intervention	Phase
Arthritis	Drug: PN 400 Drug: EC naproxen plus EC esomeprazole Drug: EC naproxen Drug: EC esomeprazole	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	A Randomized, Open-Label, 4-Way Crossover Study to Evaluate Naproxen and Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400, Enteric-Coated Naproxen 500mg Plus Enteric-Coated Esomeprazole 20mg, Enteric-Coated Naproxen 500mg Alone, and Enteric-Coated Esomeprazole 20mg Alone.

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by POZEN:

Primary Outcome Measures:

To assess the single-dose pharmacokinetics and relative bioavailability of esomeprazole in PN 400 (naproxen 500mg / esomeprazole 20mg), the enteric-coated (EC) naproxen 500mg plus EC esomeprazole 20mg and the EC esomeprazole 20mg alone treatments [ Time Frame: 12-72 hour PK assessments ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the single-dose pharmacokinetics and relative bioavailability of naproxen in PN 400 (naproxen 500mg / esomeprazole 20mg, the EC naproxen 500mg plus EC esomeprazole 20mg, and the EC naproxen 500mg alone treatments. [ Time Frame: 72-hour PK assessments ] [ Designated as safety issue: No ]
To evaluate the safety of each of the single-dose treatments [ Time Frame: Entire study duration (48 days) ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	August 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 PN 400	Drug: PN 400 A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)
Active Comparator: 2 Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg)	Drug: EC naproxen plus EC esomeprazole Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg) Other Name: EC Naprosyn and Nexium
Active Comparator: 3 Enteric-coated naproxen tablet (500mg)	Drug: EC naproxen Enteric-coated naproxen tablet (500mg) Other Name: EC Naprosyn
Active Comparator: 4 EC esomeprazole capsule (20mg)	Drug: EC esomeprazole Enteric-coated esomeprazole capsule (20mg) Other Name: Nexium

Detailed Description:

This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated esomeprazole 20mg administered alone.

Eligibility

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

Criteria

Inclusion Criteria:

Healthy males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.

Exclusion Criteria:

Standard exclusion criteria for a study of this nature - no significant medical conditions that might affect the interpretation of the PK data or compromise the safety of the subject.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749385

Locations

United States, Texas
PPD
Austin, Texas, United States, 78744

Sponsors and Collaborators

POZEN

More Information

No publications provided

Responsible Party:	David Taylor, POZEN
ClinicalTrials.gov Identifier:	NCT00749385 History of Changes
Other Study ID Numbers:	PN400-114
Study First Received:	September 5, 2008
Last Updated:	December 19, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Joint Diseases
Musculoskeletal Diseases
Naproxen
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013