Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301 in Healthy Adults

NCT07017335 | Completed Phase 1

• 1 other identifier: PBK_M2301_101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, open-label, randomized, crossover clinical trial designed to evaluate the potential drug-drug interaction (DDI) between R1\_PBK\_M2301 (levodropropizine 60 mg) and R2\_PBK\_M2301 (Pelargonium sidoides ethanol extract 11%) in healthy adult volunteers. The study aims to assess the pharmacokinetics of each investigational drug when administered alone and in combination. Approximately \[insert number\] healthy subjects will participate in two treatment periods with appropriate washout intervals. Safety, tolerability, and pharmacokinetic parameters will be evaluated to support future combination development.

Conditions

Drug-Drug Interaction Healthy Volunteers

Keywords

Drug-Drug Interaction; Levodropropizine; Pelargonium sidoides; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax) of R1_PBK_M2301 and R2_PBK_M2301

  Evaluation of potential pharmacokinetic interaction between R1\_PBK\_M2301 and R2\_PBK\_M2301 by comparing Cmax values after single oral administration alone and in combination in healthy adult subjects.

  Up to 48 hours post-dose per treatment period

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC₀-t)

  Evaluation of potential pharmacokinetic interaction between R1\_PBK\_M2301 and R2\_PBK\_M2301 by comparing AUC₀-t values after single oral administration alone and in combination in healthy adult subjects.

  Up to 48 hours post-dose per treatment period

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC₀-∞)

  Evaluation of potential pharmacokinetic interaction between R1\_PBK\_M2301 and R2\_PBK\_M2301 by comparing AUC₀-∞ values after single oral administration alone and in combination in healthy adult subjects.

  Up to 48 hours post-dose per treatment period

Study Arms (2)

R1_PBK_M2301 Administration

EXPERIMENTAL

Participants in this arm will receive R1\_PBK\_M2301, which contains 60 mg of levodropropizine per tablet, to evaluate drug-drug interactions.

Drug: R1_PBK_M2301(Levocloperastine 60mg)

R2_PBK_M2301 Administration

EXPERIMENTAL

Participants in this arm will receive R2\_PBK\_M2301, which contains 20 mg of Pelargonium sidoides ethanol extract (11%) per tablet, to evaluate drug-drug interactions.

Drug: R2_PBK_M2301 (Pelargonium sidoides extract)

Interventions

R1_PBK_M2301(Levocloperastine 60mg) DRUG

R1\_PBK\_M2301 is a test drug containing 60mg of levocloperastine per tablet. It is administered orally to evaluate pharmacokinetic characteristics and potential drug-drug interactions with R2\_PBK\_M2301 in healthy adult volunteers.

R1_PBK_M2301 Administration

R2_PBK_M2301 (Pelargonium sidoides extract) DRUG

R2\_PBK\_M2301 is an oral tablet containing 20 mg of Pelargonium sidoides 11% ethanol extract, used as a comparator to evaluate potential pharmacokinetic interactions with R1\_PBK\_M2301.

R2_PBK_M2301 Administration

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female adults aged ≥19 and \<65 years at the time of screening.
• 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.
• 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).
• 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).
• Willing and able to voluntarily provide written informed consent after receiving detailed information about the study, and agrees to comply with study requirements.
• 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.

You may not qualify if:

• 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.
• Participation in another clinical trial involving administration of an investigational drug or bioequivalence study within 6 months prior to the first dose.
• 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.
• History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
• 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.
• 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

Sponsors & Collaborators

• Pharmbio Korea Co., Ltd.: lead

Study Sites (1)

H+ Yangji Hospital

Seoul, Seoul, 08799, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No parties, including participants, investigators, or outcomes assessors, are masked to intervention assignments.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, parallel-group, open-label, Phase 1 study to evaluate the drug-drug interaction (DDI) between R1\_PBK\_M2301 (levodropropizine) and R2\_PBK\_M2301 (Pelargonium sidoides dry extract) in healthy adult volunteers. Participants will be assigned to two arms to receive either R1\_PBK\_M2301 or R2\_PBK\_M2301 followed by co-administration, in parallel design.

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 12, 2025
• Study Start: June 1, 2025
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)