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Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301 in Healthy Adults

NCT07017335 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

  • Drug-Drug Interaction Healthy Volunteers

Interventions

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.

Sponsors & Collaborators

  • Pharmbio Korea Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-07-30
Completion
2025-08-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07017335 on ClinicalTrials.gov