The primary objective of this study is to determine the relative bioavailability of treprostinil (TRE) between the TPIP F2 and TPIP F3 at 3 capsule strengths, dose A, dose B, and dose C, in healthy participants following a single inhalation of TPIP dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
USA001
Salt Lake City, Utah, United States
Maximum Observed Plasma Concentration (Cmax) of Treprostinil (TRE)
Time frame: Pre-dose and post-dose at multiple timepoints up to Day 10
Area Under Plasma Concentration-Time Curve From 0 to Last Time Point With Quantifiable Concentration (AUClast) of TRE
Time frame: Pre-dose and post-dose at multiple timepoints up to Day 10
Area Under Plasma Concentration-Time Curve From 0 to Infinity (AUCinf) of TRE
Time frame: Pre-dose and post-dose at multiple timepoints up to Day 10
Time to Reach Maximum Observed Plasma Concentration (Tmax) of TRE
Time frame: Pre-dose and post-dose at multiple timepoints up to Day 10
Terminal Elimination Half-Life (t1/2) of TRE
Time frame: Pre-dose and post-dose at multiple timepoints up to Day 10
Apparent Clearance Following Inhalation Administration (CL/F) of TRE
Time frame: Pre-dose and post-dose at multiple timepoints up to Day 10
Apparent Volume of Distribution at Terminal Phase (Vz/F) of TRE
Time frame: Pre-dose and post-dose at multiple timepoints up to Day 10
Dose-Normalized Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf/D) of TRE
Time frame: Pre-dose and post-dose at multiple timepoints up to Day 10
Dose-Normalized Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable (AUClast/D) of TRE
Time frame: Pre-dose and post-dose at multiple timepoints up to Day 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dose-Normalized Cmax and Calculated as Cmax/Dose of TRE
Time frame: Pre-dose and post-dose at multiple timepoints up to Day 10
Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAEs)
Time frame: Up to Day 17