Trials / Completed
CompletedNCT01165476
Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities
An Evaluation of the Comparative Bioavailability of a Single Oral Dose of 1mg UT-15C (Treprostinil Diethanolamine) SR Tablets Manufactured by Two Independent Facilities Administered to Healthy Volunteers in the Fed State
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- United Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Treprostinil diethanolamine | sustained release tablets. One 1mg tablet per period. Two total doses. |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2010-08-01
- Completion
- 2010-08-01
- First posted
- 2010-07-19
- Last updated
- 2011-04-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01165476. Inclusion in this directory is not an endorsement.