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Three Times Daily Dosing of UT-15C

This study has been completed.
Information provided by (Responsible Party):
United Therapeutics Identifier:
First received: August 16, 2012
Last updated: December 10, 2012
Last verified: December 2012
To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers

Condition Intervention Phase
Healthy Drug: UT-15C Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects

Resource links provided by NLM:

Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing. [ Time Frame: 6 days ]
    Cmax, tmax, AUC(0-6), AUC(0-24), AUC(6-12), AUC(12-24) and t1/2

Secondary Outcome Measures:
  • PK profile of UT-15C after a single 0.5mg dose on Day 1 [ Time Frame: 1 day ]
    Day 1: Cmax, tmax, AUC(0-6), AUC(0-24), AUC(0-t), AUC(0-inf), and t1/2

Enrollment: 19
Study Start Date: July 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UT-15C Drug: UT-15C
Other Names:
  • treprostinil diethanolamine
  • treprostinil diolamine
  • UT-15C SR


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  • Healthy male and female subjects
  • aged 18-55 years of age;
  • weight between 50 and 100 kg, with a body mass index (BMI) between 19.0 and 29.9 kg/m2, inclusive for female subjects and
  • weight between 50 and 120 kg, with a BMI between 19.0 and 32.0 kg/m², inclusive for male subjects.
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Please refer to this study by its identifier: NCT01746485

United States, Texas
PPD Development
Austin, Texas, United States
Sponsors and Collaborators
United Therapeutics
Principal Investigator: Theresa Pham, MD PPD
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: United Therapeutics Identifier: NCT01746485     History of Changes
Other Study ID Numbers: TDE-DU-102
Study First Received: August 16, 2012
Last Updated: December 10, 2012

Keywords provided by United Therapeutics:

Additional relevant MeSH terms:
Antihypertensive Agents processed this record on August 16, 2017