A Study of Compare the Pharmacokinetic, Pharmacodynamic and Safety/Tolerability Characteristics Following Multiple Oral Administration of AD-234, AD-2341, and AD-2342 in Healthy Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AD-234, AD-2341, AD-2342.
- Who it may be relevant to
- Registry conditions: Gastritis. Basic parameters: 19 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Open-label, 6-sequence, 3-period Crossover Clinical Trial to Compare the Pharmacokinetic, Pharmacodynamic and Safety/Tolerability Characteristics Following Multiple Oral Administration of AD-234, AD-2341, and AD-2342 in Healthy Adult Volunteers.
Overview
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-234, AD-2341, AD-2342 in healthy subjects.
Detailed description
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-234 compared with AD-2341, AD-2342 in healthy subjects.
Interventions
- Drug AD-234
AD-234 tablet administered orally - Drug AD-2341
AD-2341 tablet administered orally - Drug AD-2342
AD-2342 tablet administered orally
Primary outcome measures
- Percent of Time With Gastric pH ≥4 During the 24-hour Interval After the 7th Dose [Time frame: From pre-dose (0h) on Day 7 to 24 hours post-dose on Day 7 of each treatment period (Period 1: Day 7-Day 8; Period 2: Day 28-Day 29; Period 3: Day 49-Day 50)]
Eligibility criteria
Inclusion criteria
- Healthy adult volunteers aged 19 to 50 years, inclusive, at the time of screening
- Body weight between 50.0 kg and 90.0 kg, inclusive, and body mass index (BMI) between 18.5 kg/m\^2 and 29.9 kg/m\^2, inclusive, at the time of screening (BMI = weight \[kg\] / height \[m\]\^2)
- For female participants: not pregnant, not breastfeeding, or surgically sterile (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
Exclusion criteria
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration Other exclusions applied
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital, Seoul, — Seoul
Identifiers
NCT: NCT07717775 · AD-234PK/PD