A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-214 to AD-2141 in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Addpharma Inc.
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- AUCtau,ss(Area under the plasma drug concentration-time curve)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
R-T
Period 1 : Test Drug(AD-214) Period 2 : Reference Drug(AD-2141)
Intervention: AD-214 (Drug)
R-T
Period 1 : Test Drug(AD-214) Period 2 : Reference Drug(AD-2141)
Intervention: AD-2141 (Drug)
T-R
Period 1 : Reference Drug(AD-2141) Period 2 : Test Drug(AD-214)
Intervention: AD-214 (Drug)
T-R
Period 1 : Reference Drug(AD-2141) Period 2 : Test Drug(AD-214)
Intervention: AD-2141 (Drug)
Outcomes
Primary Outcomes
AUCtau,ss(Area under the plasma drug concentration-time curve)
Time Frame: 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)
Time Frame: Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
Evaluation PD Rabeprazole after multiple dose
Secondary Outcomes
- AUCtau(Area under the plasma drug concentration-time curve)(Day1)
- Cmax(Maximum concentration of drug in plasma)(Day1)
- Tmax(Time to maximum plasma concentration)(Day1)
- t1/2(Terminal elimination half-life)(Day1)
- CL/F(Apparent clearance)(Day1)
- CLss/F(Apparent Clearance at steady state)(From Day 1 up to Day 29)
- Vss/F(Apparent Volume of distribution at steady state)(From Day 1 up to Day 29)
- Vd/F(Apparent volume of distribution)(Day1)
- t1/2,ss(Terminal elimination half-life at steady state)(From Day 1 up to Day 29)
- Cmax,ss(Maximum concentration of drug in plasma at steady state)(From Day 1 up to Day 29)
- Cav,ss(Average concentration of drug in plasma at steady state)(From Day 1 up to Day 29)
- 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)
- Tmax,ss(Time to maximum plasma concentration at steady state)(From Day 1 up to Day 29)
- PTF(Peak trough fluctuation over one dosing interal at steady state)(From Day 1 up to Day 29)
- After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours(Day1 24hours monitoring)
- 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)
- 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)