Actively Recruiting
A Randomized, Open-label, Single-dose, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of AD-115A and the Administration of AD-1151 for Healthy Subjects in Fasting State
Led by Addpharma Inc. ยท Updated on 2026-02-11
46
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and how the body processes two different oral drugs, AD-115A and AD-1151, in healthy adults. This study focuses on comparing these two treatments to understand their pharmacokinetics and safety when taken as a single dose while fasting. The trial is designed as a randomized, open-label, crossover study to carefully assess these characteristics in adult participants. Participants will take a single 200 mg oral dose of either AD-115A or AD-1151, depending on their assigned sequence in the study. The trial consists of two periods where each participant receives both drugs in a randomized order with a washout period in between. This approach helps compare the effects of each drug within the same individual. During the study, researchers will monitor drug levels in the blood over 24 hours to measure the maximum concentration and the overall exposure to the drug. Safety assessments will also be conducted throughout the trial. Participants will be required to fast before dosing, and the study will include regular visits for blood sampling and health evaluations. The entire participation will cover both dosing periods and follow-up assessments as scheduled by the trial.
CONDITIONS
Brief Title
Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older at screening
- Body mass index (BMI) between 18.0 and 30.0 kg/m2 at screening
- Healthy volunteers without significant medical conditions
You will not qualify if you...
- Use of drugs that induce or inhibit drug-metabolizing enzymes within 30 days before the first dosing day
- Use of drugs that may affect the study within 10 days before the first dosing day
- Other unspecified exclusion criteria applied by the study team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two treatment periods with washout in between (duration not specified)
Participants receive single-dose oral administration of AD-115A or AD-1151 according to a randomized sequence in two periods.
2 dosing visits with post-dose monitoring for 24 hours each
Trial Site Locations
Total: 1 location
1
H PLUS YANGJI HOSPITAL, Seoul
Seoul, South Korea
Actively Recruiting
Research Team
J
JaeHun Jung
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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