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AzTrials

Healthy VolunteersPhase 1PBK_M2301_BENCT07161180

Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults

A Phase 1 study testing PBK_M2301 (levodropropizine + Pelargonium sidoides extract), R1_PBK_M2301 (levodropropizine) and R2_PBK_M2301 (Pelargonium sidoides extract) in people with Healthy Volunteers, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
PBK_M2301 (levodropropizine + Pelargonium sidoides extract), R1_PBK_M2301 (levodropropizine) and R2_PBK_M2301 (Pelargonium sidoides extract)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSouth Korea
Study dates
27 Aug 2025to 30 Nov 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

1 Inclusion Criteria

Subjects who meet all of the following criteria may be included in the study:

  1. Male or female subjects aged 19 years or older and less than 65 years at the time of screening.
  2. 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.
  1. 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).
  2. 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).
  3. 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.
  4. 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. 2 Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study:

  1. 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.
  2. 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.
  3. 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.
  4. History of gastrointestinal resection surgery that may affect drug absorption (excluding appendectomy or hernia repair).
  5. 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.
  1. 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.
  • Severe hepatic impairment.
  • Severe liver disease or severe renal disease.
  • Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  1. History of clinically significant psychiatric disorders.
  2. Any other reason, not specified in the inclusion/exclusion criteria, that in the opinion of the principal investigator (or a sub-investigator) makes the subject unsuitable for participation.
  3. For female subjects: pregnant, suspected of being pregnant, or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Manager Clinical Trial Team, Pharmbio Korea NA contact

+92-2-587-2551

cr@pharmbio.co.kr

South Korea1 site, 1 recruiting
  • H+ Yangji Hospital

    Seoul, Seoul, 08799

    Moonjung Bae, 82-70-4665-9174, m4222@newjh.com

    Recruiting

Other trials in South Korea

About this study

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

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?

Read more

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

Read the 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.

Being tested
PBK_M2301 (levodropropizine + Pelargonium sidoides extract), R1_PBK_M2301 (levodropropizine), R2_PBK_M2301 (Pelargonium sidoides extract)
Keywords
Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PBK_M2301 (levodropropizine + Pelargonium sidoides extract)Drug

    Also called PBK_M2301

    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.

  • R1_PBK_M2301 (levodropropizine)Drug

    Also called R1_PBK_M2301

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

  • R2_PBK_M2301 (Pelargonium sidoides extract)Drug

    Also called R2_PBK_M2301

    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.

Study groups in NCT07161180
Study groupRoleWhat they receive
Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301Active comparatorParticipants 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.
Receives: 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_M2301ExperimentalParticipants 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.
Receives: Drug: PBK_M2301 (levodropropizine + Pelargonium sidoides extract); Drug: R1_PBK_M2301 (levodropropizine); Drug: R2_PBK_M2301 (Pelargonium sidoides extract)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

Secondary outcomes (6)
  1. Area under the plasma concentration-time curve extrapolated to infinity (AUC∞) of Levodropropizine

    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.

    Measured: Pre-dose (0 hours) to last quantifiable concentration plus extrapolated terminal phase (up to 12 hours post-dose)

  2. Ratio of AUCt to AUC∞ of Levodropropizine

    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.

    Measured: Pre-dose (0 hours) to last quantifiable concentration plus extrapolated terminal phase (up to 12 hours post-dose)

  3. Time to reach maximum plasma concentration (Tmax) of Levodropropizine

    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.

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

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

    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.

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

  5. Apparent oral clearance (CL/F) of Levodropropizine

    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.

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

  6. Apparent volume of distribution (Vz/F) of Levodropropizine

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start27 Aug 2025
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion30 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07161180
Sponsor's protocol ID
PBK_M2301_102
Other IDs
PBK_M2301_102
Acronym
PBK_M2301_BE
Status last verified
Sep 2025
First submitted
20 Aug 2025
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to internal policy and data protection regulations. The dataset is limited to a small population of healthy volunteers and is intended solely for internal analysis and regulatory submission.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PBK_M2301 (levodropropizine + Pelargonium sidoides extract), R1_PBK_M2301 (levodropropizine) and R2_PBK_M2301 (Pelargonium sidoides extract) in people with Healthy Volunteers, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Manager Clinical Trial Team, Pharmbio Korea NA (+92-2-587-2551, cr@pharmbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum plasma concentration (Cmax) of Levodropropizine (time frame: Pre-dose (0 hours) to 12 hours post-dose (depending on dosing regimen)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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