A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels

NCT00749385 — Phase 1, Completed, 40 participants, POZEN

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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.

Registry	NCT00749385
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, basic science
Enrollment	40 (Actual)
Sponsor	POZEN (Industry)
Conditions	Arthritis
Interventions	PN 400, EC naproxen plus EC esomeprazole, EC naproxen, EC esomeprazole (Drug)
Dates	start 2008-08-01, primary completion 2008-10-01, completion 2008-10-01, first posted 2008-09-09, last updated 2008-12-23
Locations	1 site in United States

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: PN 400	PN 400
2	Active comparator	Drug: EC naproxen plus EC esomeprazole	Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg)
3	Active comparator	Drug: EC naproxen	Enteric-coated naproxen tablet (500mg)
4	Active comparator	Drug: EC esomeprazole	EC esomeprazole capsule (20mg)

PN 400 (Drug): A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)
EC naproxen plus EC esomeprazole (Drug), also known as EC Naprosyn and Nexium: Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)
EC naproxen (Drug), also known as EC Naprosyn: Enteric-coated naproxen tablet (500mg)
EC esomeprazole (Drug), also known as Nexium: Enteric-coated esomeprazole capsule (20mg)

+Outcome measures

Primary outcomes

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 [12-72 hour PK assessments]

Secondary outcomes

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. [72-hour PK assessments]
To evaluate the safety of each of the single-dose treatments [Entire study duration (48 days)]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
PPD	Austin, Texas	United States

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