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This study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine tablet strengths in healthy volunteers.
This study was designed to assess the pharmacokinetic linearity and comparative bioavailability of UT-15C SR (treprostinil diethanolamine) following the administration of a single tablet containing 0.5 mg, 1 mg and 2.5 mg UT-15C in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 mg treprostinil diethanolamine | Experimental | 0.5 mg treprostinil diethanolamine |
|
| 2.5 mg treprostinil diethanolamine | Experimental | 2.5 mg treprostinil diethanolamine |
|
| 1 mg treprostinil diethanolamine | Experimental | 1 mg treprostinil diethanolamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treprostinil diethanolamine | Drug | Treprostinil diethanolamine sustained release oral tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treprostinil pharmacokinetics | Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine sustained release tablets immediately prior to through 36 hours post treprostinil diethanolamine dosing. | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical laboratories | Study Days 0, 7, 14 and 16. | |
| Adverse event monitoring | From the first dose of treprostinil diethanolamine through the end of the study (Study Day 16) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas L Hunt, MD, PhD | 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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