Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults

NCT07161180 | Recruiting Phase 1

• 1 other identifier: PBK_M2301_102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration (Cmax) of Levodropropizine

  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.

  Pre-dose (0 hours) to 12 hours post-dose (depending on dosing regimen)

• Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUCt) of Levodropropizine

  AUCt will be calculated using the linear trapezoidal method based on plasma concentration-time data, in accordance with "Regulations on Bioequivalence Tests" (Article 17).

  Pre-dose (0 hours) to 12 hours post-dose (depending on dosing regimen)

Secondary Outcomes (6)

• 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)

• 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)

• Time to reach maximum plasma concentration (Tmax) of Levodropropizine

  Pre-dose (0 hours) to 12 hours post-dose

• Terminal elimination half-life (t1/2) of Levodropropizine

  From Cmax to terminal phase (up to 12 hours post-dose)

• Apparent oral clearance (CL/F) of Levodropropizine

  From dosing to terminal phase (up to 12 hours post-dose)

Study Arms (2)

Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301

ACTIVE COMPARATOR

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.

Drug: PBK_M2301 (levodropropizine + Pelargonium sidoides extract); Drug: R1_PBK_M2301 (levodropropizine); Drug: R2_PBK_M2301 (Pelargonium sidoides extract)

Arm 2: PBK_M2301 Followed by R1_PBK_M2301 + R2_PBK_M2301

EXPERIMENTAL

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.

Drug: PBK_M2301 (levodropropizine + Pelargonium sidoides extract); Drug: R1_PBK_M2301 (levodropropizine); Drug: R2_PBK_M2301 (Pelargonium sidoides extract)

Interventions

PBK_M2301 (levodropropizine + Pelargonium sidoides extract) DRUG

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.

Also known as: PBK_M2301

Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301; Arm 2: PBK_M2301 Followed by R1_PBK_M2301 + R2_PBK_M2301

R1_PBK_M2301 (levodropropizine) DRUG

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

Also known as: R1_PBK_M2301

Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301; Arm 2: PBK_M2301 Followed by R1_PBK_M2301 + R2_PBK_M2301

R2_PBK_M2301 (Pelargonium sidoides extract) DRUG

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.

Also known as: R2_PBK_M2301

Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301; Arm 2: PBK_M2301 Followed by R1_PBK_M2301 + R2_PBK_M2301

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who meet all of the following criteria may be included in the study:
• Male or female subjects aged 19 years or older and less than 65 years at the time of screening.
• Body mass index (BMI) between 18 and 30 kg/m² (inclusive) at screening (BMI = weight (kg) / height (m)²):
• For male subjects: body weight ≥ 50 kg.
• For female subjects: body weight ≥ 45 kg.
• No clinically significant congenital or chronic diseases, and no pathological symptoms or findings based on internal medicine examination (including, if necessary, electroencephalography, electrocardiography, chest and/or upper gastrointestinal endoscopy, or gastrointestinal radiographic examination).
• Judged by the principal investigator (or a sub-investigator) to be suitable for participation based on diagnostic tests performed according to the characteristics of the investigational product, including hematology, clinical chemistry, coagulation, serology, urinalysis, and electrocardiography (ECG).
• Voluntarily decides to participate after receiving and fully understanding a detailed explanation of the study, and signs the written informed consent form, agreeing to comply with the study requirements during the study period.
• Agrees to use medically acceptable contraception\* (excluding hormonal contraceptives) from the first administration of the investigational product until 1 week after the last administration, to prevent pregnancy in themselves or their spouse/partner, and agrees not to donate sperm or ova during this period.
• Medically acceptable contraception: intrauterine device (IUD), intrauterine system (IUS), vasectomy, tubal ligation, or a combination of barrier methods (male condom, female condom, cervical cap, diaphragm, contraceptive sponge). When using spermicide, at least two barrier methods should be used in combination.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study:
• Use of enzyme-inducing or enzyme-inhibiting drugs such as barbiturates within 30 days prior to the first administration, or use of any drugs that may interfere with the study within 10 days prior to the first administration.
• Participation in a bioequivalence study or any other clinical trial and administration of an investigational product within 6 months prior to the first administration in this study.
• Whole blood donation within 8 weeks, component blood donation within 2 weeks, or receipt of a blood transfusion within 4 weeks prior to the first administration in this study.
• History of gastrointestinal resection surgery that may affect drug absorption (excluding appendectomy or hernia repair).
• Within 1 month prior to the first administration:
• For male subjects: average alcohol consumption \> 21 units/week.
• For female subjects: average alcohol consumption \> 14 units/week.
• (1 unit = 50 mL soju, 250 mL beer, or 30 mL whisky)
• Average smoking \> 20 cigarettes/day.
• Presence of the following conditions:
• Known hypersensitivity to the investigational product or any of its components.
• Bronchial hypersecretion.
• Mucociliary dysfunction (e.g., Kartagener syndrome, primary ciliary dyskinesia).
• Increased bleeding tendency or use of anticoagulant therapy.

Sponsors & Collaborators

• Pharmbio Korea Co., Ltd.: lead

Study Sites (1)

H+ Yangji Hospital

Seoul, Seoul, 08799, South Korea

RECRUITING

MeSH Terms

Interventions

dipropizine

Central Study Contacts

Manager Clinical Trial Team, Pharmbio Korea NA

CONTACT

+92-2-587-2551; cr@pharmbio.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No parties, including participants, investigators, care providers, or outcome assessors, are masked to treatment assignments.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label, randomized, two-period, two-sequence crossover study in 32 healthy adult volunteers. Participants will receive a single oral dose of PBK\_M2301 or a combination of two reference drugs (R1\_PBK\_M2301 and R2\_PBK\_M2301) in a randomized order, with a one-week washout between treatments.

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 8, 2025
• Study Start: August 27, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)