Clinical Trial

Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults

Study acronym: PBK_M2301_BE
Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated September 12, 2025 (before its estimated October 30, 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-03.
Status change: Not Yet Recruiting → Recruiting 2025-09-07
Trial Details
NCT Number NCT07161180
Lead Sponsor Pharmbio Korea Co., Ltd.
Conditions Healthy Volunteers
Enrollment 32 participants
Start Date 2025-08-27
Primary Completion 2025-10-30 (estimated)
Study Completion 2025-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-12