PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00599404 |
Recruitment Status
:
Completed
First Posted
: January 23, 2008
Last Update Posted
: April 30, 2008
|
Sponsor:
POZEN
Information provided by:
POZEN
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: PN400 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |
Resource links provided by the National Library of Medicine

Drug Information available for:
Esomeprazole
U.S. FDA Resources
Intervention Details:
-
Drug: PN400
500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9
Primary Outcome Measures
:
- Pharmacokinetic profile following dosing with PN400 [ Time Frame: 24-hour PK on Day 1 & Day 10 of each treatment period ]
Secondary Outcome Measures
:
- To evaluate the safety of PN400 [ Time Frame: Day 1-10 of each treatment period ]
Information from the National Library of Medicine

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
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
No Contacts or Locations Provided
Responsible Party: | David Taylor, Pozen |
ClinicalTrials.gov Identifier: | NCT00599404 History of Changes |
Other Study ID Numbers: |
PN400-111 |
First Posted: | January 23, 2008 Key Record Dates |
Last Update Posted: | April 30, 2008 |
Last Verified: | April 2008 |
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 |