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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 is a Phase 1 study that has completed, run by United Therapeutics. The registered enrollment target is 64 participants.

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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.

Interventions

  • DRUG Treprostinil diethanolamine

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2010-07
Est. Completion 2010-08
Phase Phase 1

Sponsor

United Therapeutics

63 total trials

What the Registry Record Tells You About NCT01165476

The ClinicalTrials.gov registry entry for NCT01165476 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Treprostinil diethanolamine is the first listed.

NCT01165476 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.