A Phase 1 Clinical Trial to Evaluate the Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of R1_PBK_M2301 and R2_PBK_M2301
研究概览
简要总结
This is a Phase 1, open-label, randomized, crossover clinical trial designed to evaluate the potential drug-drug interaction (DDI) between R1_PBK_M2301 (levodropropizine 60 mg) and R2_PBK_M2301 (Pelargonium sidoides ethanol extract 11%) in healthy adult volunteers. The study aims to assess the pharmacokinetics of each investigational drug when administered alone and in combination. Approximately [insert number] healthy subjects will participate in two treatment periods with appropriate washout intervals. Safety, tolerability, and pharmacokinetic parameters will be evaluated to support future combination development.
详细描述
This Phase 1 clinical trial is designed to assess potential drug-drug interactions between R1_PBK_M2301 (levodropropizine 60 mg) and R2_PBK_M2301 (Pelargonium sidoides 11% ethanol extract) in healthy adult volunteers. The study adopts an open-label, randomized, two-period crossover design. Each participant will receive both investigational products in different periods, with a washout interval between treatments.
The primary objective is to compare the pharmacokinetic parameters (e.g., C_max, AUC) of the individual drugs when administered alone versus in combination. Secondary objectives include evaluating safety and tolerability through clinical assessments, vital signs, ECGs, and laboratory tests.
Approximately 24 healthy adults will be enrolled. Each subject will be screened for eligibility based on predefined inclusion and exclusion criteria. Eligible participants will be randomly assigned to one of two sequence groups. Blood samples will be collected at predetermined time points to analyze plasma concentrations of the study drugs.
The findings of this study are expected to support further clinical development and regulatory planning for the combination use of levodropropizine and Pelargonium sidoides extract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
This is an open-label study. No parties, including participants, investigators, or outcomes assessors, are masked to intervention 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
R1_PBK_M2301 Administration
Participants in this arm will receive R1_PBK_M2301, which contains 60 mg of levodropropizine per tablet, to evaluate drug-drug interactions.
干预措施: R1_PBK_M2301(Levocloperastine 60mg) (Drug)
R2_PBK_M2301 Administration
Participants in this arm will receive R2_PBK_M2301, which contains 20 mg of Pelargonium sidoides ethanol extract (11%) per tablet, to evaluate drug-drug interactions.
干预措施: R2_PBK_M2301 (Pelargonium sidoides extract) (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of R1_PBK_M2301 and R2_PBK_M2301
时间窗: Up to 48 hours post-dose per treatment period
Evaluation of potential pharmacokinetic interaction between R1\_PBK\_M2301 and R2\_PBK\_M2301 by comparing Cmax values after single oral administration alone and in combination in healthy adult subjects.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC₀-t)
时间窗: Up to 48 hours post-dose per treatment period
Evaluation of potential pharmacokinetic interaction between R1\_PBK\_M2301 and R2\_PBK\_M2301 by comparing AUC₀-t values after single oral administration alone and in combination in healthy adult subjects.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC₀-∞)
时间窗: Up to 48 hours post-dose per treatment period
Evaluation of potential pharmacokinetic interaction between R1\_PBK\_M2301 and R2\_PBK\_M2301 by comparing AUC₀-∞ values after single oral administration alone and in combination in healthy adult subjects.
次要结局
未报告次要终点