A Phase 1 Clinical Trial to Evaluate the Pharmacokinetic Characteristics of "PBK_M2301" in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of Levodropropizine
研究概览
简要总结
The goal of this Phase 1 clinical trial is to evaluate the safety and pharmacokinetic characteristics of PBK_M2301 in healthy adult volunteers. The main questions it aims to answer are:
What are the maximum concentration (Cmax) and total drug exposure (AUCt) of PBK_M2301 compared to the combination of two reference drugs?
Are there any safety concerns associated with a single oral dose of PBK_M2301?
Researchers will compare PBK_M2301 with the combination of R1_PBK_M2301 and R2_PBK_M2301 to assess differences in drug levels.
Participants will:
Receive each treatment once in a randomized sequence with a one-week washout in between
Provide blood samples at multiple time points after dosing
Undergo safety assessments including adverse event monitoring, vital signs, laboratory tests, and ECGs
详细描述
This Phase 1, open-label, randomized, two-period, two-sequence crossover study will evaluate the safety and pharmacokinetic characteristics of PBK_M2301 in 32 healthy adults. PBK_M2301 contains levodropropizine 60 mg and Pelargonium sidoides extract 20 mg per tablet.
Participants will receive either a single dose of PBK_M2301 or a combination of two reference drugs (R1_PBK_M2301 and R2_PBK_M2301) in a randomized sequence, with a one-week washout between treatments. Blood samples will be collected at multiple time points up to 12 hours post-dose to determine plasma concentrations of levodropropizine using a validated LC-MS/MS method.
Primary endpoints are Cmax and AUCt, with secondary endpoints including AUC∞, Tmax, t1/2, CL/F, and Vz/F. Safety will be assessed by monitoring adverse events, vital signs, laboratory tests, and ECGs throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
This is an open-label study. No parties, including participants, investigators, care providers, or outcome assessors, are masked to treatment assignments.
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older 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
Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301
Participants in this arm will receive a single oral dose of R1_PBK_M2301 (levodropropizine 60 mg) plus R2_PBK_M2301 (Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of PBK_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.
干预措施: PBK_M2301 (levodropropizine + Pelargonium sidoides extract) (Drug)
Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301
Participants in this arm will receive a single oral dose of R1_PBK_M2301 (levodropropizine 60 mg) plus R2_PBK_M2301 (Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of PBK_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.
干预措施: R1_PBK_M2301 (levodropropizine) (Drug)
Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301
Participants in this arm will receive a single oral dose of R1_PBK_M2301 (levodropropizine 60 mg) plus R2_PBK_M2301 (Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of PBK_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.
干预措施: R2_PBK_M2301 (Pelargonium sidoides extract) (Drug)
Arm 2: PBK_M2301 Followed by R1_PBK_M2301 + R2_PBK_M2301
Participants in this arm will receive a single oral dose of PBK_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of R1_PBK_M2301 (levodropropizine 60 mg) plus R2_PBK_M2301 (Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.
干预措施: PBK_M2301 (levodropropizine + Pelargonium sidoides extract) (Drug)
Arm 2: PBK_M2301 Followed by R1_PBK_M2301 + R2_PBK_M2301
Participants in this arm will receive a single oral dose of PBK_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of R1_PBK_M2301 (levodropropizine 60 mg) plus R2_PBK_M2301 (Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.
干预措施: R1_PBK_M2301 (levodropropizine) (Drug)
Arm 2: PBK_M2301 Followed by R1_PBK_M2301 + R2_PBK_M2301
Participants in this arm will receive a single oral dose of PBK_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of R1_PBK_M2301 (levodropropizine 60 mg) plus R2_PBK_M2301 (Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.
干预措施: R2_PBK_M2301 (Pelargonium sidoides extract) (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of Levodropropizine
时间窗: Pre-dose (0 hours) to 12 hours post-dose (depending on dosing regimen)
Cmax will be determined from plasma concentration-time data following single and multiple oral doses of PBK\_M2301, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUCt) of Levodropropizine
时间窗: Pre-dose (0 hours) to 12 hours post-dose (depending on dosing regimen)
AUCt will be calculated using the linear trapezoidal method based on plasma concentration-time data, in accordance with "Regulations on Bioequivalence Tests" (Article 17).
次要结局
- Area under the plasma concentration-time curve extrapolated to infinity (AUC∞) of Levodropropizine(Pre-dose (0 hours) to last quantifiable concentration plus extrapolated terminal phase (up to 12 hours post-dose))
- Ratio of AUCt to AUC∞ of Levodropropizine(Pre-dose (0 hours) to last quantifiable concentration plus extrapolated terminal phase (up to 12 hours post-dose))
- Time to reach maximum plasma concentration (Tmax) of Levodropropizine(Pre-dose (0 hours) to 12 hours post-dose)
- Terminal elimination half-life (t1/2) of Levodropropizine(From Cmax to terminal phase (up to 12 hours post-dose))
- Apparent oral clearance (CL/F) of Levodropropizine(From dosing to terminal phase (up to 12 hours post-dose))
- Apparent volume of distribution (Vz/F) of Levodropropizine(From dosing to terminal phase (up to 12 hours post-dose))