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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:


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:
    Drug: PN400
    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