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This is a single center, open-label, two-period study. There will be nine healthy human volunteers arbitrarily assigned to one of four groups. The study objective is to compare the action of various combinations of BiDil extended-release capsules and commercial BiDil Tablets in the body over a period of time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | ISDN/HYD 2 SR caps crossover to 1 IR cap at 8 am |
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| Group 2 | Experimental | ISDN/HYD 2 SR caps crossover to 1 IR cap at 5 pm |
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| Group 3 | Experimental | ISDN/HYD 2 SR caps crossover to 1 IR cap at 8 pm |
|
| Group 4 | Active Comparator | ISDN/HYD 1 IR cap and two SR caps at 8 am crossover to Day 8: BiDil Tablet tid |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosorbide dinitrate / hydralazine capsules | Drug | Group 1: Day 1:Two SR capsules; Day 8: One IR capsule Group 2: Day 1:Two SR capsules; Day 8: One IR capsule Group 3: Day 1:Two SR capsules; Day 8: One IR capsule Group 4: Day 1:One IR capsule and two SR capsules; Day 8: Commercial BiDil Tablet tid |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma/blood concentration versus time curve, as calculated by the linear trapezoidal method for Hydralazine and ISDN and metabolites. | from time zero (0) to 24 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory J Tracey, MD | Frontage Laboratories, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frontage Cinical Services | Hackensack | New Jersey | 07601 | United States |
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| ID | Term |
|---|---|
| D007548 | Isosorbide Dinitrate |
| D006830 | Hydralazine |
| ID | Term |
|---|---|
| D007547 | Isosorbide |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Organic Chemicals |
| D002241 | Carbohydrates |
| D010793 | Phthalazines |
| D011724 | Pyridazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |