Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-65
SponsorPharmbio Korea Co., Ltd.
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Male or female subjects aged 19 years or older and less than 65 years at the time of screening.
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).
Disqualifiers
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).
Trial design
Design model
Crossover
Treatments tested in this trial
PBK_M2301 (levodropropizine + Pelargonium sidoides extract)
DrugA 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.
R1_PBK_M2301 (levodropropizine)
DrugA single oral tablet containing levodropropizine 60 mg. Administered after at least 10 hours of fasting with 150 mL of water at room temperature.
R2_PBK_M2301 (Pelargonium sidoides extract)
DrugA 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Arm 1: R1_PBK_M2301 + R2_PBK_M2301 Followed by PBK_M2301Active comparator 3 interventions
Group B: Arm 2: PBK_M2301 Followed by R1_PBK_M2301 + R2_PBK_M2301Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Maximum plasma concentration (Cmax) of Levodropropizine
Cmax will be determined from plasma concentration-time data following single and multiple oral doses of PBK\_M2301, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Time frame
Pre-dose (0 hours) to 12 hours post-dose (depending on dosing regimen)2
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUCt) of Levodropropizine
AUCt will be calculated using the linear trapezoidal method based on plasma concentration-time data, in accordance with "Regulations on Bioequivalence Tests" (Article 17).
Time frame
Pre-dose (0 hours) to 12 hours post-dose (depending on dosing regimen)Secondary outcomes
1
Area under the plasma concentration-time curve extrapolated to infinity (AUC∞) of Levodropropizine
AUC∞ will be derived as the sum of AUCt and the extrapolated terminal area (Ct/λZ) using noncompartmental analysis, following single and multiple oral doses of Levodropropizine, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Time frame
Pre-dose (0 hours) to last quantifiable concentration plus extrapolated terminal phase (up to 12 hours post-dose)2
Ratio of AUCt to AUC∞ of Levodropropizine
The percentage of AUCt relative to AUC∞ will be calculated for each participant to assess the proportion of the observed exposure, following single and multiple oral doses of Levodropropizine, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Time frame
Pre-dose (0 hours) to last quantifiable concentration plus extrapolated terminal phase (up to 12 hours post-dose)3
Time to reach maximum plasma concentration (Tmax) of Levodropropizine
Tmax will be recorded as the actual observed time of maximum plasma concentration for each participant after single and multiple oral doses of Levodropropizine, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Time frame
Pre-dose (0 hours) to 12 hours post-dose4
Terminal elimination half-life (t1/2) of Levodropropizine
t1/2 will be estimated from the terminal slope of the log-linear portion of the plasma concentration-time curve after single and multiple oral doses of Levodropropizine, administered alone and in combination with R1\_PBK\_M2301 or R2\_PBK\_M2301.
Time frame
From Cmax to terminal phase (up to 12 hours post-dose)Sponsors and contacts
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Source ClinicalTrials.gov