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

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.
ClinicalTrials.gov Identifier: NCT00599404
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : April 30, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: PN400 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : January 2008
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: PN400
    500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9

Outcome Measures

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

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

Eligibility Criteria

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

More Information

Responsible Party: David Taylor, Pozen
ClinicalTrials.gov Identifier: NCT00599404     History of Changes
Other Study ID Numbers: PN400-111
First Posted: January 23, 2008    Key Record Dates
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