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
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.
Description
This study is designed to evaluate the effect of different dosing times of PN 200 relative to food on the intragastric pH profile of PN 200. PN 200 contains immediate release omeprazole, which may be subject to acid degradation in the stomach. Food is known to have a buffering effect on acid and therefore may result in less degradation of immediate release omeprazole. Alternatively, food may decrease the absorption of omeprazole in the duodenum. The relative magnitude of these effects is unknown. The data from this study will aid in choosing the optimal timing of PN dosing relative to food in future studies. The study is not blinded because the primary endpoint (intragastric pH) is a physiological variable not believed to be readily influenced by conscious or subconscious subject control.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Healthy
Intervention
PN 200
Location
Pozen Inc.
Chapel Hill
North Carolina
United States
27517
Status
Completed
Source
POZEN
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00442208
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Clinical Trials
None
PubMed Articles
None
