Actively Recruiting
Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults
Led by Pharmbio Korea Co., Ltd. · Updated on 2025-09-12
32
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 19 years or older and less than 65 years at screening
- Body mass index (BMI) between 18 and 30 kg/m²
- Males must weigh at least 50 kg; females at least 45 kg
- No clinically significant congenital or chronic diseases or abnormal findings in medical exams
- Suitable for participation based on diagnostic tests including hematology, chemistry, coagulation, serology, urinalysis, and ECG
- Voluntarily agrees to participate and signs informed consent
- Agrees to use medically acceptable contraception (excluding hormonal methods) from first dose until one week after last dose to prevent pregnancy and not to donate sperm or ova during this period
You will not qualify if you...
- Use of enzyme-inducing or inhibiting drugs within 30 days or interfering drugs within 10 days before first dose
- Participation in another clinical trial or investigational drug use within 6 months prior to first dose
- Blood donation within 8 weeks (whole blood) or 2 weeks (component) or blood transfusion within 4 weeks before first dose
- History of gastrointestinal surgery affecting drug absorption (except appendectomy or hernia repair)
- Excessive alcohol use within 1 month prior to first dose (males >21 units/week; females >14 units/week)
- Smoking more than 20 cigarettes per day within 1 month prior to first dose
- Known hypersensitivity to study drug or components
- Bronchial hypersecretion or mucociliary dysfunction
- Increased bleeding tendency or anticoagulant therapy
- Severe liver or kidney disease
- Hereditary conditions like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- History of significant psychiatric disorders
- Pregnant, suspected pregnant, or breastfeeding females
- Any other condition judged by investigators to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
H+ Yangji Hospital
Seoul, Seoul, South Korea, 08799
Actively Recruiting
Research Team
M
Manager Clinical Trial Team, Pharmbio Korea NA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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