Trials / Completed
CompletedNCT00599404
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- POZEN · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400 tablets from the same drug product batch.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PN400 | 500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9 |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2008-01-23
- Last updated
- 2008-04-30
Source: ClinicalTrials.gov record NCT00599404. Inclusion in this directory is not an endorsement.