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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
History of Changes
  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:

U.S. FDA Resources

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
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, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
 Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013