Gastroesophageal Reflux Disease
Conditions
Brief summary
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 to AD-2141 in healthy volunteers.
Detailed description
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214 compared with administration of AD-2141 in healthy volunteers.
Interventions
DRUGAD-214
1 tablet administered before the breakfast during 7 days
DRUGAD-2141
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
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 19\ 50 years in healthy volunteers * BMI is more than 18.0 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 | Evaluateion PK Rabeprazole after multiple dose |
| Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity) | Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring | Evaluation PD Rabeprazole after multiple dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax(Time to maximum plasma concentration) | Day1 | Evaluation PK Rabeprazole after single dose |
| t1/2(Terminal elimination half-life) | Day1 | Evaluation PK Rabeprazole after single dose |
| CL/F(Apparent clearance) | Day1 | Evaluation PK Rabeprazole after single dose |
| Vd/F(Apparent volume of distribution) | Day1 | Evaluation PK Rabeprazole after single dose |
| Cmax,ss(Maximum concentration of drug in plasma at steady state) | From Day 1 up to Day 29 | Evaluation PK Rabeprazole 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 Rabeprazole after multiple dose |
| Cav,ss(Average concentration of drug in plasma at steady state) | From Day 1 up to Day 29 | Evaluation PK Rabeprazole after multiple dose |
| AUCtau(Area under the plasma drug concentration-time curve) | Day1 | Evaluation PK Rabeprazole after single dose |
| t1/2,ss(Terminal elimination half-life at steady state) | From Day 1 up to Day 29 | Evaluation PK Rabeprazole after multiple dose |
| CLss/F(Apparent Clearance at steady state) | From Day 1 up to Day 29 | Evaluation PK Rabeprazole after multiple dose |
| Vss/F(Apparent Volume of distribution at steady state) | From Day 1 up to Day 29 | Evaluation PK Rabeprazole after multiple dose |
| PTF(Peak trough fluctuation over one dosing interal at steady state) | From Day 1 up to Day 29 | Evaluation PK Rabeprazole after multiple dose |
| After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours | Day1 24hours monitoring | Evaluation PD Rabeprazole |
| 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 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring | Evaluation PD Rabeprazole |
| After the first administration and 7 days of repeated administration, The median pH measured for 24 hours | Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring | Evaluation PD Rabeprazole |
| Tmax,ss(Time to maximum plasma concentration at steady state) | From Day 1 up to Day 29 | Evaluation PK Rabeprazole after multiple dose |
| Cmax(Maximum concentration of drug in plasma) | Day1 | Evaluation PK Rabeprazole after single dose |
Countries
South Korea
Outcome results
None listed