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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05062876
Other study ID # AD-214PK/PD-03
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 1, 2021
Est. completion date March 29, 2022

Study information

Verified date October 2021
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 to AD-2141 in healthy volunteers.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date March 29, 2022
Est. primary completion date March 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility 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

Study Design


Intervention

Drug:
AD-214
1 tablet administered before the breakfast during 7 days
AD-2141
1 tablet administered before the breakfast during 7 days

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUCtau,ss(Area under the plasma drug concentration-time curve) Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Primary Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity) Evaluation PD Rabeprazole after multiple dose Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
Secondary AUCtau(Area under the plasma drug concentration-time curve) Evaluation PK Rabeprazole after single dose Day1
Secondary Cmax(Maximum concentration of drug in plasma) Evaluation PK Rabeprazole after single dose Day1
Secondary Tmax(Time to maximum plasma concentration) Evaluation PK Rabeprazole after single dose Day1
Secondary t1/2(Terminal elimination half-life) Evaluation PK Rabeprazole after single dose Day1
Secondary CL/F(Apparent clearance) Evaluation PK Rabeprazole after single dose Day1
Secondary Vd/F(Apparent volume of distribution) Evaluation PK Rabeprazole after single dose Day1
Secondary Cmax,ss(Maximum concentration of drug in plasma at steady state) Evaluation PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma) Evaluation PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Cav,ss(Average concentration of drug in plasma at steady state) Evaluation PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Tmax,ss(Time to maximum plasma concentration at steady state) Evaluation PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary t1/2,ss(Terminal elimination half-life at steady state) Evaluation PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary CLss/F(Apparent Clearance at steady state) Evaluation PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Vss/F(Apparent Volume of distribution at steady state) Evaluation PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary PTF(Peak trough fluctuation over one dosing interal at steady state) Evaluation PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours Evaluation PD Rabeprazole Day1 24hours monitoring
Secondary After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours Evaluation PD Rabeprazole Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
Secondary After the first administration and 7 days of repeated administration, The median pH measured for 24 hours Evaluation PD Rabeprazole Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
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