Drug-Drug Interaction Healthy VolunteersPhase 1NCT07017335
Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301 in Healthy Adults
A Phase 1 study testing R1_PBK_M2301(Levocloperastine 60mg) and R2_PBK_M2301 (Pelargonium sidoides extract) in people with Drug-Drug Interaction Healthy Volunteers, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-Drug Interaction Healthy Volunteers
- What is being tested?
- R1_PBK_M2301(Levocloperastine 60mg) and R2_PBK_M2301 (Pelargonium sidoides extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2025to 30 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
<Inclusion Criteria>
- 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.
<Exclusion criteria>
- 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
- Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- History of clinically significant psychiatric illness.
- Any other condition deemed by the principal investigator (or sub-investigator) to render the subject unsuitable for study participation.
- Female participants who are pregnant, suspected of being pregnant, or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301
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.
Read the detailed description
This Phase 1 clinical trial is designed to assess potential drug-drug interactions between R1_PBK_M2301 (levodropropizine 60 mg) and R2_PBK_M2301 (Pelargonium sidoides 11% ethanol extract) in healthy adult volunteers. The study adopts an open-label, randomized, two-period crossover design. Each participant will receive both investigational products in different periods, with a washout interval between treatments.
The primary objective is to compare the pharmacokinetic parameters (e.g., C_max, AUC) of the individual drugs when administered alone versus in combination. Secondary objectives include evaluating safety and tolerability through clinical assessments, vital signs, ECGs, and laboratory tests.
Approximately 24 healthy adults will be enrolled. Each subject will be screened for eligibility based on predefined inclusion and exclusion criteria. Eligible participants will be randomly assigned to one of two sequence groups. Blood samples will be collected at predetermined time points to analyze plasma concentrations of the study drugs.
The findings of this study are expected to support further clinical development and regulatory planning for the combination use of levodropropizine and Pelargonium sidoides extract.
- Conditions
- Drug-Drug Interaction Healthy Volunteers
- Being tested
- R1_PBK_M2301(Levocloperastine 60mg), R2_PBK_M2301 (Pelargonium sidoides extract)
- Keywords
- Drug-Drug Interaction, Levodropropizine, Pelargonium sidoides, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: R2_PBK_M2301 (Pelargonium sidoides extract) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 48 hours post-dose per treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jun 2025
- Primary completion30 Jul 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Drug Interaction Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmbio Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017335
- Sponsor's protocol ID
- PBK_M2301_101
- Status last verified
- Sep 2025
- First submitted
- 23 May 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to internal policy and data protection regulations. The dataset is limited to a small population of healthy volunteers and is intended solely for internal analysis and regulatory submission.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301
- ClinicalTrials.gov ID
- NCT07017335
- Acronym / sponsor ID
- PBK_M2301_101
- Conditions
- Drug-Drug Interaction Healthy Volunteers
- Keywords
- Drug-Drug Interaction, Levodropropizine, Pelargonium sidoides, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pharmbio Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Phase 1 clinical trial is designed to assess potential drug-drug interactions between R1_PBK_M2301 (levodropropizine 60 mg) and R2_PBK_M2301 (Pelargonium sidoides 11% ethanol extract) in healthy adult volunteers. The study adopts an open-label, randomized, two-period crossover design. Each participant will receive both investigational products in different periods, with a washout interval between treatments.
The primary objective is to compare the pharmacokinetic parameters (e.g., C_max, AUC) of the individual drugs when administered alone versus in combination. Secondary objectives include evaluating safety and tolerability through clinical assessments, vital signs, ECGs, and laboratory tests.
Approximately 24 healthy adults will be enrolled. Each subject will be screened for eligibility based on predefined inclusion and exclusion criteria. Eligible participants will be randomly assigned to one of two sequence groups. Blood samples will be collected at predetermined time points to analyze plasma concentrations of the study drugs.
The findings of this study are expected to support further clinical development and regulatory planning for the combination use of levodropropizine and Pelargonium sidoides extract.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| R1_PBK_M2301 Administration | Experimental | Drug: R1_PBK_M2301(Levocloperastine 60mg)Participants in this arm will receive R1_PBK_M2301, which contains 60 mg of levodropropizine per tablet, to evaluate drug-drug interactions. |
| R2_PBK_M2301 Administration | Experimental | Drug: R2_PBK_M2301 (Pelargonium sidoides extract)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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R1_PBK_M2301(Levocloperastine 60mg)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. | Drug | R1_PBK_M2301 Administration |
| R2_PBK_M2301 (Pelargonium sidoides extract)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. | Drug | R2_PBK_M2301 Administration |
Primary outcome
Peak Plasma Concentration (Cmax) of R1_PBK_M2301 and R2_PBK_M2301
Time frame: Up to 48 hours post-dose per treatment period
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.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC₀-t)
Time frame: Up to 48 hours post-dose per treatment period
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.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC₀-∞)
Time frame: Up to 48 hours post-dose per treatment period
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to internal policy and data protection regulations. The dataset is limited to a small population of healthy volunteers and is intended solely for internal analysis and regulatory submission.
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Drug Interactions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R1_PBK_M2301(Levocloperastine 60mg) and R2_PBK_M2301 (Pelargonium sidoides extract) in people with Drug-Drug Interaction Healthy Volunteers, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of R1_PBK_M2301 and R2_PBK_M2301 (time frame: Up to 48 hours post-dose per treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.