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

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00599404
First received: January 11, 2008
Last updated: April 23, 2008
Last verified: April 2008
History of Changes
  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: 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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of PN400 [ Time Frame: Day 1-10 of each treatment period ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: David Taylor, Pozen
ClinicalTrials.gov Identifier: NCT00599404     History of Changes
Other Study ID Numbers: PN400-111
Study First Received: January 11, 2008
Last Updated: April 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by POZEN:
Pharmacokinetics study

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013