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The purpose of this study is to compare the bioavailability of a single 1mg dose of treprostinil diethanolamine sustained release (SR) tablets manufactured by two independent facilities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| manufacturer #1 | Active Comparator | treprostinil diethanolamine from manufacturer #1 |
|
| manufacturer #2 | Experimental | treprostinil diethanolamine from manufacturer #2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treprostinil diethanolamine | Drug | sustained release tablets. One 1mg tablet per period. Two total doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treprostinil pharmacokinetics | Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 1mg treprostinil diethanolamine collecting pre and post-dose levels to 36 hours. | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical lab values | Days 0, 7 and 9 | |
| Adverse event monitoring | From signing of ICF to end of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aziz L Laurent, MD | PPD Development, LP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C427248 | treprostinil |
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