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The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high percentage of drug as the free base are equivalent to tablets with the standard percentage when given to participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Percentage | Experimental |
| |
| High Percentage | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | 40 mg delayed-release tablet administered orally in the morning of Days 1-7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from 0 to 72 hours (AUC[0-72h]) of SCH 530348 | Up to 72 hours after SCH 530348 dose on Day 5 | |
| Maximal plasma concentration (Cmax) of SCH 530348 | Up to 72 hours after SCH 530348 dose on Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing clinical and laboratory adverse events (AEs) | Up to 2 weeks after last dose |
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Inclusion criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| C530299 | vorapaxar |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| SCH 530348 (high percentage) | Drug | 2.5 mg tablet containing ~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5 |
|
| SCH 530348 (standard percentage) | Drug | 2.5 mg tablet containing ~23% API as free base (STANDARD) administered orally on the morning of Day 5 |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |