A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole

A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-206 to Esomeprazole in Healthy Male Volunteers

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Gastritis
• Intervention / Treatment: Drug: AD-206 20mg; Drug: Esomeprazole 20mg; Drug: AD-206 40mg; Drug: Esomeprazole 40mg

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• 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: 15 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A1; Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg)	Drug: AD-206 20mg; 1 tablet administered before the breakfast during 7 days; Other Names: Test drug; Drug: Esomeprazole 20mg; 1 tablet administered before the breakfast during 7 days; Other Names: Reference Drug
Experimental: Group A2; Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg)	Drug: AD-206 20mg; 1 tablet administered before the breakfast during 7 days; Other Names: Test drug; Drug: Esomeprazole 20mg; 1 tablet administered before the breakfast during 7 days; Other Names: Reference Drug
Experimental: Group B1; Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg)	Drug: AD-206 40mg; 1 tablet administered before the breakfast during 7 days; Other Names: Test drug; Drug: Esomeprazole 40mg; 1 tablet administered before the breakfast during 7 days; Other Names: Reference Drug
Experimental: Group B2; Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg)	Drug: AD-206 40mg; 1 tablet administered before the breakfast during 7 days; Other Names: Test drug; Drug: Esomeprazole 40mg; 1 tablet administered before the breakfast during 7 days; Other Names: Reference Drug

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 esomeprazole 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 esomeprazole after multiple dose	Day1 24hrs pH monitoring, Day7 24hrs pH monitoring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCtau(Area under the plasma drug concentration-time curve)	Evaluation PK esomeprazole after single dose	Day1
Cmax(Maximum concentration of drug in plasma)	Evaluation PK esomeprazole after single dose	Day1
Tmax(Time to maximum plasma concentration)	Evaluation PK esomeprazole after single dose	Day1
t1/2(Terminal elimination half-life)	Evaluation PK esomeprazole after single dose	Day1
CL/F(Apparent clearance)	Evaluation PK esomeprazole after single dose	Day1
Vd/F(Apparent volume of distribution)	Evaluation PK esomeprazole after single dose	Day1
Cmax,ss(Maximum concentration of drug in plasma at steady state)	Evaluation PK esomeprazole after multiple dose	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)	Evaluation PK esomeprazole after multiple dose	From Day 1 up to Day 29
Cav,ss(Average concentration of drug in plasma at steady state)	Evaluation PK esomeprazole after multiple dose	From Day 1 up to Day 29
Tmax,ss(Time to maximum plasma concentration at steady state)	Evaluation PK esomeprazole after multiple dose	From Day 1 up to Day 29
t1/2,ss(Terminal elimination half-life at steady state)	Evaluation PK esomeprazole after multiple dose	From Day 1 up to Day 29
CLss/F(Apparent Clearance at steady state)	Evaluation PK esomeprazole after multiple dose	From Day 1 up to Day 29
Vss/F(Apparent Volume of distribution at steady state)	Evaluation PK esomeprazole after multiple dose	From Day 1 up to Day 29
PTF(Peak trough fluctuation over one dosing interal at steady state)	Evaluation PK esomeprazole after multiple dose	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	Evaluation PD esomeprazole	Day1 24hrs pH 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	Evaluation PD esomeprazole	Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours	Evaluation PD esomeprazole	Day1 24hrs pH monitoring, Day7 24hrs pH monitoring

Collaborators and Investigators

• Sponsor: Addpharma Inc.
• Investigators: Principal Investigator: In-Jin Jang, M.D.,Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): April 27, 2020
• Study Completion (Actual): June 18, 2020

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: AD-206PK/PD

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