Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

Phase 1

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Treprostinil diethanolamine

• Registration Number: NCT01165476
• Lead Sponsor: United Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-19
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-18
• Last Update Posted: 2011-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
manufacturer #1	Treprostinil diethanolamine	treprostinil diethanolamine from manufacturer #1
manufacturer #2	Treprostinil diethanolamine	treprostinil diethanolamine from manufacturer #2

Primary Outcome Measures

Name	Time	Method
Treprostinil pharmacokinetics	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

Name	Time	Method
Clinical lab values	Days 0, 7 and 9
Adverse event monitoring	From signing of ICF to end of study

Trial Locations

Locations (1)

PPD Development; 🇺🇸 Austin, Texas, United States