Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults
Recruiting
Phase 1
Interventional Study
Healthy Volunteers
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 19 – 65
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 32 (estimated)
- Sponsor
- Pharmbio Korea Co., Ltd. · Industry
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About This Trial
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\…
Trial Locations
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Eligibility Criteria
1 Inclusion Criteria
Subjects who meet all of the following criteria may be included in the study:
1. Male or female subjects aged 19 years or older and less than 65 years at the time of screening.
2. Body mass index (BMI) between 18 and 30 kg/m² (inclusive) at screening (BMI = weight (kg) / heigh…
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