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

April 23, 2008 updated by: POZEN

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic profile following dosing with PN400
Time Frame: 24-hour PK on Day 1 & Day 10 of each treatment period
24-hour PK on Day 1 & Day 10 of each treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety of PN400
Time Frame: Day 1-10 of each treatment period
Day 1-10 of each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

POZEN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Estimate)

April 30, 2008

Last Update Submitted That Met QC Criteria

April 23, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PN400-111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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Locations

3
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