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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
sustained release tablets. One 1mg tablet per period. Two total doses.
PPD Development
Austin, Texas, United States
Treprostinil pharmacokinetics
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 1mg treprostinil diethanolamine collecting pre and post-dose levels to 36 hours.
Time frame: 36 hours
Clinical lab values
Time frame: Days 0, 7 and 9
Adverse event monitoring
Time frame: From signing of ICF to end of study
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