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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PN 200 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH > 4.0) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of different dosing times of PN 200 on the pharmacokinetic properties of omeprazole |
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Inclusion Criteria:
Male or non-lactating, non-pregnant female subjects who are 18-55 years of age
Female subjects are eligible for participation in the study if they are of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
Childbearing potential, have a negative pregnancy test (urine) at screening, and at least one of the following applies or is agreed to by the subject:
Physical examination findings within normal limits for age
Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Taylor | POZEN | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pozen Inc. | Chapel Hill | North Carolina | 27517 | United States |
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| ID | Term |
|---|---|
| D017275 | Isradipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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