drugset / Trial / NCT00442208
An Open-Label, Randomized, Comparative 3-Way Cross-Over Study to Evaluate the Effect of Food on the 24-Hour Intragastric pH at Day 5 After Twice Daily Oral Administration of PN 200 (Omeprazole/Naproxen) in Healthy Volunteers
RandomizedSingle-groupOpen-labelTreatment
Summary
Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH\> 4.0) following twice daily administration at different dosing times relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5.
Timeline
- Start
- 2007-01
- Primary completion
- 2008-02
- Completion
- 2008-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naproxen | Small molecule | — | Oral |
| Subject | Omeprazole | Other / unclassified | — | Oral |
Indications
No indication recorded.