Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301 in Healthy Adults

Launched by PHARMBIO KOREA CO., LTD. · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how two investigational drugs, R1_PBK_M2301 (levodropropizine) and R2_PBK_M2301 (an extract from Pelargonium sidoides), interact with each other when taken together. This is important because understanding how these drugs work together can help in developing better treatment options in the future. The trial will take place in healthy adult volunteers aged 19 to 64, who meet specific health criteria, such as having a normal body weight and no serious health issues.

Participants can expect to take part in two different treatment periods, where they will receive either of the drugs alone or in combination, with breaks in between to ensure their bodies clear the drugs. Throughout the study, researchers will monitor participants' health and how their bodies process the medications. It's important to note that participants need to agree to follow certain guidelines, including using contraception during the trial and not participating in other clinical studies at the same time. This study is currently not recruiting participants, but it aims to gather important data that could support future drug development.

Gender

ALL

Eligibility criteria

• • \<Inclusion Criteria\>
• • 1. Healthy male or female adults aged ≥19 and \<65 years at the time of screening.
• • 2. Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight \[kg\] / height² \[m²\]);
• • Male participants must weigh at least 50 kg.
• • Female participants must weigh at least 45 kg.
• • 3. No clinically significant congenital or chronic diseases, and no abnormal findings from a medical examination (e.g., electroencephalogram, electrocardiogram, chest and/or gastrointestinal endoscopy, or radiologic examinations, if deemed necessary).
• • 4. Laboratory test results (including hematology, clinical chemistry, coagulation tests, serology, urinalysis) and ECG results deemed suitable for study participation by the investigator (or sub-investigator).
• • 5. Willing and able to voluntarily provide written informed consent after receiving detailed information about the study, and agrees to comply with study requirements.
• • 6. Agrees to use medically accepted contraception methods\* from the first administration of the investigational product through 1 week after the final administration, and agrees not to donate sperm or ova during this period.
• • Medically accepted contraception includes intrauterine devices (IUD, IUS), sterilization (vasectomy or tubal ligation), or combination of barrier methods (e.g., male/female condoms, cervical caps, diaphragms, sponges), possibly with spermicide.
• • \<Exclusion criteria\>
• • 1. Use of enzyme-inducing or enzyme-inhibiting drugs such as barbiturates within 30 days prior to the first dose, or use of any medication that may interfere with the study within 10 days prior to the first dose.
• • 2. Participation in another clinical trial involving administration of an investigational drug or bioequivalence study within 6 months prior to the first dose.
• • 3. Donation of whole blood within 8 weeks, donation of blood components within 2 weeks, or receipt of blood transfusion within 4 weeks prior to the first dose.
• • 4. History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
• 5. Within 1 month prior to the first dose, meets one of the following:
• • Alcohol consumption \>21 drinks/week (males) or \>14 drinks/week (females);
• • (1 drink = 50 mL soju, 250 mL beer, or 30 mL whiskey)
• • Smoking \>20 cigarettes/day on average.
• 6. Individuals with any of the following conditions:
• • Known hypersensitivity to the investigational product or its components
• • Increased bronchial mucus secretion
• • Mucociliary dysfunction (e.g., Kartagener syndrome, primary ciliary dyskinesia)
• • Bleeding tendency or use of anticoagulants
• • Severe hepatic impairment
• • Severe liver or kidney disease
• • Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• • 7. History of clinically significant psychiatric illness.
• • 8. Any other condition deemed by the principal investigator (or sub-investigator) to render the subject unsuitable for study participation.
• • 9. Female participants who are pregnant, suspected of being pregnant, or breastfeeding.