Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults
Summary
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
Timeline
- Start
- 2025-08-27
- Primary completion
- 2025-10-30
- Completion
- 2025-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levodropropizine | Small molecule | 60 mg | Oral |
| Background | Pelargonium sidoides extract | Unknown | 20 mg | Oral |
Indications
No indication recorded.