Pulmonary Arterial Hypertension
Conditions
Keywords
treprostinil, bioavailability, bioequivalence
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.
Interventions
sustained release tablets. One 1mg tablet per period. Two total doses.
Sponsors
United Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Clinical lab values | Days 0, 7 and 9 |
| Adverse event monitoring | From signing of ICF to end of study |
Countries
United States
Outcome results
None listed