A Phase 1, Open-Label, Randomized, 3-Group, Crossover Study to Assess the Relative Bioavailability After a Single Inhalation Administration of TPIP Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Treprostinil (TRE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TPIP Dose A
Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.
干预措施: TPIP F2 (Drug)
TPIP Dose A
Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.
干预措施: TPIP F3 (Drug)
TPIP Dose B
Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.
干预措施: TPIP F2 (Drug)
TPIP Dose B
Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.
干预措施: TPIP F3 (Drug)
TPIP Dose C
Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.
干预措施: TPIP F2 (Drug)
TPIP Dose C
Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.
干预措施: TPIP F3 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Treprostinil (TRE)
时间窗: 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
时间窗: 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
时间窗: Pre-dose and post-dose at multiple timepoints up to Day 10
次要结局
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of TRE(Pre-dose and post-dose at multiple timepoints up to Day 10)
- Terminal Elimination Half-Life (t1/2) of TRE(Pre-dose and post-dose at multiple timepoints up to Day 10)
- Apparent Clearance Following Inhalation Administration (CL/F) of TRE(Pre-dose and post-dose at multiple timepoints up to Day 10)
- Apparent Volume of Distribution at Terminal Phase (Vz/F) of TRE(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(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(Pre-dose and post-dose at multiple timepoints up to Day 10)
- Dose-Normalized Cmax and Calculated as Cmax/Dose of TRE(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)(Up to Day 17)