RecruitingPhase 1NCT07161180

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

Sponsor

Pharmbio Korea Co., Ltd.

Enrollment

32 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers

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

Eligibility

Min Age: 19 YearsMax Age: 65 Years

Inclusion Criteria10

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.

Exclusion Criteria20

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.
Severe hepatic impairment.
Severe liver disease or severe renal disease.
Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
History of clinically significant psychiatric disorders.
For female subjects: pregnant, suspected of being pregnant, or breastfeeding.

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Interventions

DRUGPBK_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.

DRUGR1_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.

DRUGR2_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.