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New treatment option for Healthy Volunteers
Official title Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults
ClinicalTrials.gov ID: NCT07161180
What this study is testing
What is PBK_M2301 (levodropropizine + Pelargonium sidoides extract)?
PBK_M2301 (levodropropizine + Pelargonium sidoides extract) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy volunteers.
Also referred to as PBK_M2301.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 1 people who meet all of the following criteria may be included in the study:
- Male or female people 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 people: body weight ≥ 50 kg.
- For female people: body weight ≥ 45 kg.
You likely can't join if
- people 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...
- Participation in a bioequivalence study or any other clinical trial and administration of an investigational product within 6 months prior to the...
- 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...
- History of gastrointestinal resection surgery that may affect drug absorption (excluding appendectomy or hernia repair).
- Within 1 month prior to the first administration:
See the full eligibility criteria
- 1 people who meet all of the following criteria may be included in the study:
- Male or female people 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 people: body weight ≥ 50 kg.
- For female people: 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...
- 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...
- 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...
- 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...
- 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...
- people 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...
- 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 people: average alcohol consumption \> 21 units/week.
- For female people: 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.
- 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.
- For female people: pregnant, suspected of being pregnant, or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.