Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities
Completed · Phase 1
Conditions studied: Pulmonary Arterial Hypertension
In brief
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.
Key facts
- Study ID
- NCT01165476
- Run by
- United Therapeutics
- People needed
- 64
- Starts
- 2010-07-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2011-04-19
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, 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
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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