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Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165476
First Posted: July 19, 2010
Last Update Posted: April 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
United Therapeutics
  Purpose
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.

Condition Intervention Phase
Pulmonary Arterial Hypertension Drug: Treprostinil diethanolamine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Treprostinil pharmacokinetics [ Time Frame: 36 hours ]
    Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 1mg treprostinil diethanolamine collecting pre and post-dose levels to 36 hours.


Secondary Outcome Measures:
  • Clinical lab values [ Time Frame: Days 0, 7 and 9 ]
  • Adverse event monitoring [ Time Frame: From signing of ICF to end of study ]

Enrollment: 64
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: manufacturer #1
treprostinil diethanolamine from manufacturer #1
Drug: Treprostinil diethanolamine
sustained release tablets. One 1mg tablet per period. Two total doses.
Experimental: manufacturer #2
treprostinil diethanolamine from manufacturer #2
Drug: Treprostinil diethanolamine
sustained release tablets. One 1mg tablet per period. Two total doses.

  Eligibility

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

Inclusion Criteria:

  • Subject is healthy and between the ages of 18 and 55 years, inclusive, at Screening
  • Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening
  • Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening

Exclusion Criteria:

  • Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
  • Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug
  • Subject has a clinically significant history of neurological, cardiovascular,respiratory, endocrine, hematological, hepatic, renal, gastrointestinal,genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
  Contacts and Locations
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): NCT01165476


Locations
United States, Texas
PPD Development
Austin, Texas, United States, 78744
Sponsors and Collaborators
United Therapeutics
Investigators
Principal Investigator: Aziz L Laurent, MD PPD
  More Information

Responsible Party: Andrew Nelsen, PharmD, United Therapeutics
ClinicalTrials.gov Identifier: NCT01165476     History of Changes
Other Study ID Numbers: TDE-PH-121
First Submitted: July 15, 2010
First Posted: July 19, 2010
Last Update Posted: April 19, 2011
Last Verified: April 2011

Keywords provided by United Therapeutics:
treprostinil
bioavailability
bioequivalence

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents


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