Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single center, open label, randomized, two-period, two-sequence cross-over study is designed to evaluate the relative bioavailability of a treprostinil diethanolamine 1 mg tablet in reference to treprostinil diethanolamine 1 mg oral solution (administered as four 0.25 mg doses every 2 hours for a 1 mg total dose) in twenty-four healthy volunteers. Other secondary outcomes of interest include assessment of pharmacokinetic parameters of treprostinil diethanolamine 1 mg tablets and a treprostinil diethanolamine 1 mg oral solution administered as four doses (0.25 mg every 2 hours for a 1 mg total dose) and evaluation of the safety and tolerability of each treatment regimen.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mg tablet; 1mg solution | Experimental |
| |
| 1mg solution; 1mg tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treprostinil diethanolamine | Drug | Subjects will be administered a 1 mg dose of treprostinil diethanolamine as a single tablet, and treprostinil diethanolamine oral solution 0.25 mg dose every 2 hours for four doses (1 mg total). |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma treprostinil concentrations | Pharmacokinetic blood sampling will occur twice for each subject. Pharmacokinetic parameters will be derived from treprostinil concentration-time data | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| vital sign measurements, clinical laboratory parameters, electrocardiograms (ECGs) and adverse events (AEs) | 1 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aziz Laurent, MD | PPD Development, LP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development | Austin | Texas | 78744 | United States |
Not provided
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C427248 | treprostinil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided