How PBK_M2301 is processed in healthy adults

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

This trial will test how a single oral dose of PBK_M2301 (levodropropizine plus Pelargonium sidoides) is absorbed, distributed, and cleared in healthy adults compared with the two component drugs.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 19 Years to 65 Years
• Sex: All
• Sponsor: Pharmbio Korea Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Seoul, Seoul)
• Trial ID: NCT07161180 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label, randomized, two-period, two-sequence crossover trial will enroll 32 healthy adults to compare single doses of PBK_M2301 and the two reference drugs. Participants receive each treatment once with a one-week washout between doses and provide blood samples up to 12 hours post-dose to measure levodropropizine plasma concentrations by LC-MS/MS. Primary endpoints are Cmax and AUCt, with secondary pharmacokinetic measures including AUC∞, Tmax, t1/2, CL/F, and Vz/F. Safety is monitored throughout by adverse event reporting, vital signs, laboratory tests, and ECGs.

Who should consider this trial

Good fit: Ideal participants are healthy men or women aged 19–64 with BMI 18–30 kg/m² and no clinically significant medical conditions who meet the study's laboratory and vital sign criteria.

Not a fit: People with active medical conditions, those outside the age or BMI ranges, pregnant or breastfeeding individuals, or anyone seeking therapeutic treatment are unlikely to receive clinical benefit from participating.

Why it matters

Potential benefit: If the combination shows comparable drug levels and acceptable safety, PBK_M2301 could move forward as a combined formulation that simplifies dosing.

How similar studies have performed: Crossover pharmacokinetic comparisons of combination products versus component drugs are standard and have been used successfully in bioequivalence and formulation development.

Eligibility criteria

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.
3. 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).
4. 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).
5. 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.
6. 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.
6. 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.
7. History of clinically significant psychiatric disorders.
8. 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.
9. For female subjects: pregnant, suspected of being pregnant, or breastfeeding.

Where this trial is running

Seoul, Seoul

• H+ Yangji Hospital — Seoul, Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Manager Clinical Trial Team, Pharmbio Korea NA

Conditions Healthy Volunteers; Pharmacokinetics