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Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400 tablets from the same drug product batch.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PN400 | Drug | 500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile following dosing with PN400 | 24-hour PK on Day 1 & Day 10 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of PN400 | Day 1-10 of each treatment period |
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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
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