Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165476
• Other study ID #: TDE-PH-121
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2010
• Last updated: April 18, 2011
• Start date: July 2010
• Est. completion date: August 2010

Study information

• Verified date: April 2011
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Treprostinil diethanolamine
sustained release tablets. One 1mg tablet per period. Two total doses.

Locations

Country	Name	City	State
United States	PPD Development	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treprostinil pharmacokinetics	Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 1mg treprostinil diethanolamine collecting pre and post-dose levels to 36 hours.	36 hours	No
Secondary	Clinical lab values		Days 0, 7 and 9	Yes
Secondary	Adverse event monitoring		From signing of ICF to end of study	Yes