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Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults

NCT07161180 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-09-12

No results posted yet for this study

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

Conditions

  • Healthy Volunteers

Interventions

DRUG

PBK_M2301 (levodropropizine + Pelargonium sidoides extract)

A single oral tablet containing levodropropizine 60 mg and Pelargonium sidoides extract (11% ethanol dried extract, 5.5\~6.6→1) 20 mg. Administered after at least 10 hours of fasting with 150 mL of water at room temperature.

DRUG

R1_PBK_M2301 (levodropropizine)

A single oral tablet containing levodropropizine 60 mg. Administered after at least 10 hours of fasting with 150 mL of water at room temperature.

DRUG

R2_PBK_M2301 (Pelargonium sidoides extract)

A single oral tablet containing Pelargonium sidoides extract (11% ethanol dried extract, 5.5\~6.6→1) 20 mg. Administered after at least 10 hours of fasting with 150 mL of water at room temperature.

Sponsors & Collaborators

  • Pharmbio Korea Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2025-10-30
Completion
2025-11-30

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 NCT07161180 on ClinicalTrials.gov