drugset / Trial / NCT07017335
Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301 in Healthy Adults
RandomizedParallel-groupOpen-labelBasic science
Summary
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.
Timeline
- Start
- 2025-06-01
- Primary completion
- 2025-07-30
- Completion
- 2025-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levocloperastine | Unknown | 60 mg | Oral |
| Subject | Pelargonium sidoides extract | Unknown | 20 mg | Oral |
Indications
No indication recorded.