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PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00599404

First Posted: January 23, 2008

Last Update Posted: April 30, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

POZEN

Purpose

Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400 tablets from the same drug product batch.

Condition	Intervention	Phase
Healthy	Drug: PN400	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science
Official Title:	An Open-Label, 2-Period Pharmacokinetic Study to Evaluate the Intra-Subject Variability in Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400 Tablets

Resource links provided by NLM:

Drug Information available for: Esomeprazole

U.S. FDA Resources

Further study details as provided by POZEN:

Primary Outcome Measures:

Pharmacokinetic profile following dosing with PN400 [ Time Frame: 24-hour PK on Day 1 & Day 10 of each treatment period ]

Secondary Outcome Measures:

To evaluate the safety of PN400 [ Time Frame: Day 1-10 of each treatment period ]


Enrollment:	18
Study Start Date:	January 2008
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Intervention Details:

500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
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 inclusion criteria for a study of this nature

Contacts and Locations

No Contacts or Locations Provided

More Information


Responsible Party:	David Taylor, Pozen
ClinicalTrials.gov Identifier:	NCT00599404 History of Changes
Other Study ID Numbers:	PN400-111
First Submitted:	January 11, 2008
First Posted:	January 23, 2008
Last Update Posted:	April 30, 2008
Last Verified:	April 2008

Keywords provided by POZEN:


Pharmacokinetics study

Additional relevant MeSH terms:


Esomeprazole Anti-Ulcer Agents Gastrointestinal Agents	Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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