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

This study has been completed.
Information provided by:
POZEN Identifier:
First received: January 11, 2008
Last updated: April 23, 2008
Last verified: April 2008

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
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:

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 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 processed this record on April 21, 2014