Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301 in Healthy Adults

Phase 1

Not yet recruiting

• Conditions: Drug-Drug Interaction Healthy Volunteers
• Interventions: Drug: R1_PBK_M2301(Levocloperastine 60mg); Drug: R2_PBK_M2301 (Pelargonium sidoides extract)

• Registration Number: NCT07017335
• Lead Sponsor: Pharmbio Korea Co., Ltd.

Brief 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-23
• Study Start: 2025-06
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2025-07
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R1_PBK_M2301 Administration	R1_PBK_M2301(Levocloperastine 60mg)	Participants in this arm will receive R1_PBK_M2301, which contains 60 mg of levodropropizine per tablet, to evaluate drug-drug interactions.
R2_PBK_M2301 Administration	R2_PBK_M2301 (Pelargonium sidoides extract)	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.

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of R1_PBK_M2301 and R2_PBK_M2301	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)	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-∞)	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.

Trial Locations

Locations (1)

H+ Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of