Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'
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-115A, AD-1151.
- Who it may be relevant to
- Registry conditions: Gastric Ulcer. Basic parameters: from 19 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 →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.
Detailed description
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
Interventions
- Drug AD-115A, AD-1151
Single-dose oral administration of AD-115A or AD-1151 (200 mg tablet), according to randomized sequence.
Primary outcome measures
- Maximum concentration of drug in plasma (Cmax) [Time frame: pre-dose to 24 hours]
- Area under the plasma concentration-time curve during dosing interval (AUCt) [Time frame: pre-dose to 24 hours]
Eligibility criteria
Inclusion criteria
- The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
- Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
Exclusion criteria
- Individuals who have taken drugs that induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the start of the study (first dosing day), or have taken drugs that may affect this study within 10 days prior to the start of the study (first dosing day)
- Other exclusions applied
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- H PLUS YANGJI HOSPITAL, Seoul — Seoul
Identifiers
NCT: NCT07385235 · AD-115BE-02