NCT07017335

Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301 in Healthy Adults

A Phase 1 Clinical Trial to Evaluate the Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pharmbio Korea Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Drug-Drug Interaction Healthy Volunteers

Interventions

Type	Name	Description
DRUG	R1_PBK_M2301(Levocloperastine 60mg)	R1\_PBK\_M2301 is a test drug containing 60mg of levocloperastine per tablet. It is administered orally to evaluate pharmacokinetic characteristics and potential drug-drug interactions with R2\_PBK\_M2301 in healthy adult volunteers.
DRUG	R2_PBK_M2301 (Pelargonium sidoides extract)	R2\_PBK\_M2301 is an oral tablet containing 20 mg of Pelargonium sidoides 11% ethanol extract, used as a comparator to evaluate potential pharmacokinetic interactions with R1\_PBK\_M2301.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-07-30
• Completion: 2025-08-30
• First posted: 2025-06-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: South Korea