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 I

Drug Information available for:

Naproxen sodium Naproxen Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study

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.

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
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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

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

Responsible Party:	POZEN ( David Taylor )
Study ID Numbers:	PN400-114
First Received:	September 5, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00749385
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Naphazoline

Oxymetazoline

Naproxen

Musculoskeletal Diseases

Guaifenesin

Phenylephrine

Joint Diseases

Arthritis

Omeprazole

Phenylpropanolamine

Healthy

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Gastrointestinal Agents

Enzyme Inhibitors

Gout Suppressants

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Ulcer Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2008

Sponsored by:	Pozen
Information provided by:	Pozen
ClinicalTrials.gov Identifier:	NCT00749385