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RECRUITING
NCT07161180
PHASE1

Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults

Sponsor: Pharmbio Korea Co., Ltd.

View on ClinicalTrials.gov

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

Official title: A Phase 1 Clinical Trial to Evaluate the Pharmacokinetic Characteristics of "PBK_M2301" in Healthy Adult Volunteers

Key Details

Gender

All

Age Range

19 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-08-27

Completion Date

2025-11-30

Last Updated

2025-09-12

Healthy Volunteers

Yes

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.

Locations (1)

H+ Yangji Hospital

Seoul, Seoul, South Korea