The purpose of this study is to evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics.
This open-label study will evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics following a single 1 mg oral dose of UT-15C SR in healthy volunteers.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth immediately following breakfast before and after repeated daily dosing with esomeprazole.
Each subject will receive a single 40 mg capsule of esomeprazole by mouth in the morning for seven days.
PPD Development
Austin, Texas, United States
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of a 1 mg treprostinil diethanolamine sustained release tablet before and after repeated dosing with esomeprazole.
Time frame: Within 10 minutes prior to through 36 hours post treprostinil diethanolamine dosing
Adverse event monitoring
Time frame: Time Frame: From the first dose of treprostinil diethanolamine through study end (Study Day 9/10)
Clinical laboratories
Time frame: Study Days 0 and 9
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