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Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults
Sponsor: Pharmbio Korea Co., Ltd.
Summary
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
Official title: A Phase 1 Clinical Trial to Evaluate the Pharmacokinetic Characteristics of "PBK_M2301" in Healthy Adult Volunteers
Key Details
Gender
All
Age Range
19 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-08-27
Completion Date
2025-11-30
Last Updated
2025-09-12
Healthy Volunteers
Yes
Conditions
Interventions
PBK_M2301 (levodropropizine + Pelargonium sidoides extract)
A 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)
A 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)
A 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.
Locations (1)
H+ Yangji Hospital
Seoul, Seoul, South Korea