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

Information source: POZEN
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis

Intervention: PN 400 (Drug); EC naproxen plus EC esomeprazole (Drug); EC naproxen (Drug); EC esomeprazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: POZEN

Summary

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

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: 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

Secondary outcome:

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.

To evaluate the safety of each of the single-dose treatments

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

PPD, Austin, Texas 78744, United States
Additional Information

Starting date: August 2008
Last updated: December 19, 2008

Page last updated: August 23, 2015

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