Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults
Recruiting now · Phase 1
Conditions studied: Healthy Volunteers
In brief
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
Key facts
- Study ID
- NCT07161180
- Run by
- Pharmbio Korea Co., Ltd.
- People needed
- 32
- Starts
- 2025-08-27
- Expected to finish
- 2025-11-30
- Last updated by the study team
- 2025-09-12
Who can join
Age: 19 and older, up to 65. Sex: any. Healthy volunteers: accepted.
Where it is running
- H+ Yangji Hospital — Seoul, Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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