Condition: Healthy Volunteers · Sponsor: Pharmbio Korea Co., Ltd.
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
This description comes directly from the study's public registry record.
Manager Clinical Trial Team, Pharmbio Korea NA · +92-2-587-2551 · cr@pharmbio.co.kr
Always discuss trial participation with your own doctor first.
| H+ Yangji Hospital | Seoul, Seoul, South Korea | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07161180