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

Tracking Information
First Received Date ^ICMJE	January 11, 2008
Last Updated Date	April 23, 2008
Start Date ^ICMJE	January 2008
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 23, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: January 22, 2008)	To evaluate plasma esomeprazole levels following dosing with PN400 [ Time Frame: 24-hour PK on Day 1 & Day 10 of each treatment period ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00599404 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 22, 2008)	To evaluate the safety of PN400 [ Time Frame: Day 1-10 of each treatment period ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400
Official Title ^ICMJE	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
Brief Summary	Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400 tablets from the same drug product batch.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: PN400 500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	18
Completion Date	February 2008
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00599404
Other Study ID Numbers ^ICMJE	PN400-111
Has Data Monitoring Committee	No
Responsible Party	David Taylor, Pozen
Study Sponsor ^ICMJE	POZEN
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	POZEN
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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