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NCT01165476 · ClinicalTrials.gov registry record · Phase 1
Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities
A Phase 1 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT01165476: Completed Phase 1 study, sponsored by United Therapeutics.
NCT01165476 is a Phase 1 study that has completed, run by United Therapeutics. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01165476, a Phase 1 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study 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.
Primary Outcome
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 1mg treprostinil diethanolamine collecting pre and post-dose levels to 36 hours.
Interventions
- DRUG Treprostinil diethanolamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2010-07 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
What the finished NCT01165476 record still lists
NCT01165476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Treprostinil diethanolamine is the first listed.
NCT01165476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01165476 about?
NCT01165476 is a clinical study titled "Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities". 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.
What is the current status of trial NCT01165476?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2010-07. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01165476?
The interventions under investigation include: Treprostinil diethanolamine (DRUG).
Who is sponsoring clinical trial NCT01165476?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01165476's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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