NCT07161180

Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Pharmbio Korea Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

This Phase 1, open-label, randomized, two-period, two-sequence crossover study will evaluate the safety and pharmacokinetic characteristics of PBK\_M2301 in 32 healthy adults. PBK\_M2301 contains levodropropizine 60 mg and Pelargonium sidoides extract 20 mg per tablet. Participants will receive either a single dose of PBK\_M2301 or a combination of two reference drugs (R1\_PBK\_M2301 and R2\_PBK\_M2301) in a randomized sequence, with a one-week washout between treatments. Blood samples will be collected at multiple time points up to 12 hours post-dose to determine plasma concentrations of levodropropizine using a validated LC-MS/MS method. Primary endpoints are Cmax and AUCt, with secondary endpoints including AUC∞, Tmax, t1/2, CL/F, and Vz/F. Safety will be assessed by monitoring adverse events, vital signs, laboratory tests, and ECGs throughout the study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-27
• Primary completion: 2025-10-30
• Completion: 2025-11-30
• First posted: 2025-09-08
• Last updated: 2025-09-12

Locations

1 site across 1 country: South Korea