Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults

Not Applicable

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: PBK_M2301 (levodropropizine + Pelargonium sidoides extract); Drug: R1_PBK_M2301 (levodropropizine); Drug: R2_PBK_M2301 (Pelargonium sidoides extract)

• Registration Number: NCT07161180
• Lead Sponsor: Pharmbio Korea Co., Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2025-08-20
• Study Start: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-07
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-12
• Primary Completion: 2025-10-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301	PBK_M2301 (levodropropizine + Pelargonium sidoides extract)	Participants in this arm will receive a single oral dose of R1\_PBK\_M2301 (levodropropizine 60 mg) plus R2\_PBK\_M2301 (Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of PBK\_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.
Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301	R1_PBK_M2301 (levodropropizine)	Participants in this arm will receive a single oral dose of R1\_PBK\_M2301 (levodropropizine 60 mg) plus R2\_PBK\_M2301 (Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of PBK\_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.
Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301	R2_PBK_M2301 (Pelargonium sidoides extract)	Participants in this arm will receive a single oral dose of R1\_PBK\_M2301 (levodropropizine 60 mg) plus R2\_PBK\_M2301 (Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of PBK\_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.
Arm 2: PBK_M2301 Followed by R1_PBK_M2301 + R2_PBK_M2301	PBK_M2301 (levodropropizine + Pelargonium sidoides extract)	Participants in this arm will receive a single oral dose of PBK\_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of R1\_PBK\_M2301 (levodropropizine 60 mg) plus R2\_PBK\_M2301 (Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.
Arm 2: PBK_M2301 Followed by R1_PBK_M2301 + R2_PBK_M2301	R1_PBK_M2301 (levodropropizine)	Participants in this arm will receive a single oral dose of PBK\_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of R1\_PBK\_M2301 (levodropropizine 60 mg) plus R2\_PBK\_M2301 (Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.
Arm 2: PBK_M2301 Followed by R1_PBK_M2301 + R2_PBK_M2301	R2_PBK_M2301 (Pelargonium sidoides extract)	Participants in this arm will receive a single oral dose of PBK\_M2301 (levodropropizine 60 mg + Pelargonium sidoides extract 20 mg) in Period 1, followed by a one-week washout, and then a single oral dose of R1\_PBK\_M2301 (levodropropizine 60 mg) plus R2\_PBK\_M2301 (Pelargonium sidoides extract 20 mg) in Period 2. All doses will be administered after at least 10 hours of fasting, with 150 mL of water at room temperature.

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of Levodropropizine	Pre-dose (0 hours) to 12 hours post-dose (depending on dosing regimen)	Cmax will be determined from plasma concentration-time data following single and multiple oral doses of PBK\_M2301, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUCt) of Levodropropizine	Pre-dose (0 hours) to 12 hours post-dose (depending on dosing regimen)	AUCt will be calculated using the linear trapezoidal method based on plasma concentration-time data, in accordance with "Regulations on Bioequivalence Tests" (Article 17).

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve extrapolated to infinity (AUC∞) of Levodropropizine	Pre-dose (0 hours) to last quantifiable concentration plus extrapolated terminal phase (up to 12 hours post-dose)	AUC∞ will be derived as the sum of AUCt and the extrapolated terminal area (Ct/λZ) using noncompartmental analysis, following single and multiple oral doses of Levodropropizine, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Ratio of AUCt to AUC∞ of Levodropropizine	Pre-dose (0 hours) to last quantifiable concentration plus extrapolated terminal phase (up to 12 hours post-dose)	The percentage of AUCt relative to AUC∞ will be calculated for each participant to assess the proportion of the observed exposure, following single and multiple oral doses of Levodropropizine, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Time to reach maximum plasma concentration (Tmax) of Levodropropizine	Pre-dose (0 hours) to 12 hours post-dose	Tmax will be recorded as the actual observed time of maximum plasma concentration for each participant after single and multiple oral doses of Levodropropizine, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Terminal elimination half-life (t1/2) of Levodropropizine	From Cmax to terminal phase (up to 12 hours post-dose)	t1/2 will be estimated from the terminal slope of the log-linear portion of the plasma concentration-time curve after single and multiple oral doses of Levodropropizine, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Apparent oral clearance (CL/F) of Levodropropizine	From dosing to terminal phase (up to 12 hours post-dose)	CL/F will be calculated as the ratio of dose to AUC∞ using noncompartmental methods, following single and multiple oral doses of Levodropropizine, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Apparent volume of distribution (Vz/F) of Levodropropizine	From dosing to terminal phase (up to 12 hours post-dose)	Vz/F will be estimated using noncompartmental analysis based on plasma concentration-time data following single and multiple oral doses of Levodropropizine, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.

Trial Locations

Locations (1)

H+ Yangji Hospital; 🇰🇷 Seoul, Seoul, South Korea