A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
42actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-19 | actual | When the study began enrolling |
| Primary completion | 2025-10-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-03 | actual | The whole study's end, after follow-up |
| First posted | 2025-08-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteers
Interventions
- Drug: TPIP F2 — also filed as INS1009
- Drug: TPIP F3 — also filed as INS1009
Primary outcomes
what the primary-completion date above is the date OFMaximum Observed Plasma Concentration (Cmax) of Treprostinil (TRE)
measured 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
measured 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
measured Pre-dose and post-dose at multiple timepoints up to Day 10
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