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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

January 11, 2008
April 23, 2008
January 2008
February 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00599404 on ClinicalTrials.gov Archive Site
To evaluate the safety of PN400 [ Time Frame: Day 1-10 of each treatment period ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400
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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Drug: PN400
500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
February 2008
February 2008   (final data collection date for primary outcome measure)

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

Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00599404
PN400-111
No
David Taylor, Pozen
POZEN
Not Provided
Not Provided
POZEN
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP