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.
This study was designed to assess the pharmacokinetic linearity and comparative bioavailability of UT-15C SR (treprostinil diethanolamine) following the administration of a single tablet containing 0.5 mg, 1 mg and 2.5 mg UT-15C in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Treprostinil diethanolamine sustained release oral tablets.
PPD Development
Austin, Texas, United States
Treprostinil pharmacokinetics
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine sustained release tablets immediately prior to through 36 hours post treprostinil diethanolamine dosing.
Time frame: 36 hours
Clinical laboratories
Time frame: Study Days 0, 7, 14 and 16.
Adverse event monitoring
Time frame: From the first dose of treprostinil diethanolamine through the end of the study (Study Day 16)
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