Gastric Ulcer
Conditions
Brief summary
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
DRUGAD-115A, AD-1151
Single-dose oral administration of AD-115A or AD-1151 (200 mg tablet), according to randomized sequence.
Sponsors
Addpharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration of drug in plasma (Cmax) | pre-dose to 24 hours | Cmax of AD-115A |
| Area under the plasma concentration-time curve during dosing interval (AUCt) | pre-dose to 24 hours | AUCt of AD-115A |
Countries
South Korea
Contacts
CONTACTJaeHun Jung
Outcome results
None listed