Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

This study has been completed.
Sponsor:
Information provided by:
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01165476
First received: July 15, 2010
Last updated: April 18, 2011
Last verified: April 2011
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Adverse event monitoring [ Time Frame: From signing of ICF to end of study ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Andrew Nelsen, PharmD, United Therapeutics
ClinicalTrials.gov Identifier: NCT01165476     History of Changes
Other Study ID Numbers: TDE-PH-121
Study First Received: July 15, 2010
Last Updated: April 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
treprostinil
bioavailability
bioequivalence

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014