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
NCT07102316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2025-11-21
Summary
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.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
TPIP F2
Inhalation using a capsule-based dry powder inhaler device.
- DRUG
-
TPIP F3
Inhalation using a capsule-based dry powder inhaler device.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-08-19
- Primary Completion
- 2025-10-25
- Completion
- 2025-11-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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