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:

Drug Information available for: Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

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:

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:


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

ClinicalTrials.gov processed this record on September 26, 2016

To Top