A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole

A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-214-02 to Rabeprazole in Healthy Volunteers

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214-02 to Rabeprazole in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: AD-214-02; Drug: Rabeprazole

Detailed Description

This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214-02 compared with administration of Rabeprazole in healthy volunteers.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AD-214-02/Rabeprazole; Period 1 : Test Drug(AD-214-02) Period 2 : Reference Drug(Rabeprazole)	Drug: AD-214-02; 1 tablet administered before the breakfast during 7 days; Drug: Rabeprazole; 1 tablet administered before the breakfast during 7 days
Experimental: Rabeprazole/AD-214; Period 1 : Reference Drug(Rabeprazole) Period 2 : Test Drug(AD-214-02)	Drug: AD-214-02; 1 tablet administered before the breakfast during 7 days; Drug: Rabeprazole; 1 tablet administered before the breakfast during 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCtau,ss(Area under the plasma drug concentration-time curve)	Evaluation PK Rabeprazole after multiple dose	From Day 1 up to Day 29
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCtau(Area under the plasma drug concentration-time curve)	Evaluation PK Rabeprazole after single dose	Day1
Cmax(Maximum concentration of drug in plasma)	Evaluation PK Rabeprazole after single dose	Day1
Tmax(Time to maximum plasma concentration)	Evaluation PK Rabeprazole after single dose	Day1
t1/2(Terminal elimination half-life)	Evaluation PK Rabeprazole after single dose	Day1
Cmax,ss(Maximum concentration of drug in plasma at steady state)	Evaluation PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Tmax,ss(Time to maximum plasma concentration at steady state)	Evaluation PK Rabeprazole after multiple dose	From Day 1 up to Day 29
t1/2,ss(Terminal elimination half-life at steady state)	Evaluation PK Rabeprazole after multiple dose	From Day 1 up to Day 29
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 Rabeoprazoke	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	Evaluation PD Rabeoprazoke	Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring

Collaborators and Investigators

• Sponsor: Addpharma Inc.
• Investigators: Principal Investigator: Seunghwan Lee, M.D.,Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2020
• Primary Completion (Actual): March 8, 2021
• Study Completion (Actual): March 8, 2021

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: AD-214PK/PD-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No