Gastroesophagus Reflux Disease
Conditions
Brief summary
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers.
Interventions
DRUGAD-213-A
1 tablet administered before the breakfast during 5 days
DRUGAD-2131
1 tablet administered before the breakfast during 5 days
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
Yes
Inclusion criteria
* Healthy adults over 19 years of age. * Weight is more than 50kg and BMI is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2. * Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials. * Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.
Exclusion criteria
* A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug. * As a result of laboratory tests, the following figures: ALT or AST or total bilirubin \> 1.5 times upper limit of normal range. * As a result of laboratory tests, the following figures: Creatinine clearance \< 80mL/min. * Subjects who judged ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCtau | From Day 1 up to Day 17 | Evaluation PK after multiple dose |
| Integrated gastric acidity(%Decrease form baseline) | 4 times from Day -1 to Day 17 | Evaluation PD after multiple dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf | Day 1 | Evaluation PK after single dose |
| Tmax | Day 1 | Evaluation PK after single dose |
| t1/2 | Day 1 | Evaluation PK after single dose |
| CL/F | Day 1 | Evaluation PK after single dose |
| Vd/F | Day 1 | Evaluation PK after single dose |
| Cmax,ss | From Day 1 up to Day 17 | Evaluation PK after multiple dose |
| Cmax | Day 1 | Evaluation PK after single dose |
| Tmax,ss | From Day 1 up to Day 17 | Evaluation PK after multiple dose |
| CLss/F | From Day 1 up to Day 17 | Evaluation PK after multiple dose |
| Vdss/F | From Day 1 up to Day 17 | Evaluation PK after multiple dose |
| Integrated gastric acidity(Variations form baseline) | 4 times from Day -1 to Day 17 | Evaluation PD after multiple dose |
| Percentage of time to maintain gastric pH 4.0 or higher | 4 times from Day -1 to Day 17 | Evaluation PD after multiple dose |
| Cmin,ss | From Day 1 up to Day 17 | Evaluation PK after multiple dose |
| AUClast | Day 1 | Evaluation PK after single dose |
Countries
South Korea
Outcome results
None listed