Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

Completed · Phase 1

Conditions studied: Pulmonary Arterial Hypertension

In brief

This study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine tablet strengths in healthy volunteers.

Key facts

Study ID

NCT01153386

Run by

United Therapeutics

People needed

36

Starts

2010-07-01

Expected to finish

2010-08-01

Last updated by the study team

2010-08-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is healthy and between the ages of 18 and 55 years
• Female subjects must weigh between 55 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 55 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.

You may not qualify if…

• 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.

Where it is running

• PPD Development — Austin, Texas, United States

Full record on ClinicalTrials.gov

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