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
Qualifiers
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
Treatments tested in this trial
- PBK_M2301 (levodropropizine + Pelargonium sidoides extract)
- R1_PBK_M2301 (levodropropizine)
- R2_PBK_M2301 (Pelargonium sidoides extract)
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov