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Three Times Daily Dosing of UT-15C

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ClinicalTrials.gov Identifier: NCT01746485
Recruitment Status : Completed
First Posted : December 11, 2012
Last Update Posted : December 12, 2012
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: UT-15C Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects
Study Start Date : July 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: UT-15C Drug: UT-15C
Other Names:
  • treprostinil diethanolamine
  • treprostinil diolamine
  • UT-15C SR



Primary Outcome Measures :
  1. 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 :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746485


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01746485     History of Changes
Other Study ID Numbers: TDE-DU-102
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by United Therapeutics:
Volunteers

Additional relevant MeSH terms:
Treprostinil
Antihypertensive Agents