Gastritis
Conditions
Brief summary
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.
Detailed description
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of AD-206 compared with administration of Esomeprazole in healthy male subjects.
Interventions
DRUGAD-206 20mg
1 tablet administered before the breakfast during 7 days
1 tablet administered before the breakfast during 7 days
DRUGAD-206 40mg
1 tablet administered before the breakfast during 7 days
DRUGEsomeprazole 40mg
1 tablet administered before the breakfast during 7 days
Sponsors
Addpharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 19\ 50 years in healthy male volunteers * BMI is more than 18 kg/m\^2 , no more than 27.0 kg/m\^2 * Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion criteria
* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system * Subjects who judged ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCtau,ss(Area under the plasma drug concentration-time curve) | From Day 1 up to Day 29 | Evaluation PK esomeprazole after multiple dose |
| Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity) | Day1 24hrs pH monitoring, Day7 24hrs pH monitoring | Evaluation PD esomeprazole after multiple dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax(Time to maximum plasma concentration) | Day1 | Evaluation PK esomeprazole after single dose |
| t1/2(Terminal elimination half-life) | Day1 | Evaluation PK esomeprazole after single dose |
| CL/F(Apparent clearance) | Day1 | Evaluation PK esomeprazole after single dose |
| Vd/F(Apparent volume of distribution) | Day1 | Evaluation PK esomeprazole after single dose |
| Cmax,ss(Maximum concentration of drug in plasma at steady state) | From Day 1 up to Day 29 | Evaluation PK esomeprazole after multiple dose |
| Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma) | From Day 1 up to Day 29 | Evaluation PK esomeprazole after multiple dose |
| Cav,ss(Average concentration of drug in plasma at steady state) | From Day 1 up to Day 29 | Evaluation PK esomeprazole after multiple dose |
| AUCtau(Area under the plasma drug concentration-time curve) | Day1 | Evaluation PK esomeprazole after single dose |
| t1/2,ss(Terminal elimination half-life at steady state) | From Day 1 up to Day 29 | Evaluation PK esomeprazole after multiple dose |
| CLss/F(Apparent Clearance at steady state) | From Day 1 up to Day 29 | Evaluation PK esomeprazole after multiple dose |
| Vss/F(Apparent Volume of distribution at steady state) | From Day 1 up to Day 29 | Evaluation PK esomeprazole after multiple dose |
| PTF(Peak trough fluctuation over one dosing interal at steady state) | From Day 1 up to Day 29 | Evaluation PK esomeprazole after multiple dose |
| After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours | Day1 24hrs pH monitoring | Evaluation PD esomeprazole |
| After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours | Day1 24hrs pH monitoring, Day7 24hrs pH monitoring | Evaluation PD esomeprazole |
| After the first administration and 7 days of repeated administration, The median pH measured for 24 hours | Day1 24hrs pH monitoring, Day7 24hrs pH monitoring | Evaluation PD esomeprazole |
| Tmax,ss(Time to maximum plasma concentration at steady state) | From Day 1 up to Day 29 | Evaluation PK esomeprazole after multiple dose |
| Cmax(Maximum concentration of drug in plasma) | Day1 | Evaluation PK esomeprazole after single dose |
Countries
South Korea
Outcome results
None listed