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

Primary Purpose

Gastritis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-206 20mg
Esomeprazole 20mg
AD-206 40mg
Esomeprazole 40mg
Sponsored by
Addpharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastritis

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A1

Group A2

Group B1

Group B2

Arm Description

Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg)

Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg)

Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg)

Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg)

Outcomes

Primary Outcome Measures

AUCtau,ss(Area under the plasma drug concentration-time curve)
Evaluation PK esomeprazole after multiple dose
Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)
Evaluation PD esomeprazole after multiple dose

Secondary Outcome Measures

AUCtau(Area under the plasma drug concentration-time curve)
Evaluation PK esomeprazole after single dose
Cmax(Maximum concentration of drug in plasma)
Evaluation PK esomeprazole after single dose
Tmax(Time to maximum plasma concentration)
Evaluation PK esomeprazole after single dose
t1/2(Terminal elimination half-life)
Evaluation PK esomeprazole after single dose
CL/F(Apparent clearance)
Evaluation PK esomeprazole after single dose
Vd/F(Apparent volume of distribution)
Evaluation PK esomeprazole after single dose
Cmax,ss(Maximum concentration of drug in plasma at steady state)
Evaluation PK esomeprazole after multiple dose
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
Cav,ss(Average concentration of drug in plasma at steady state)
Evaluation PK esomeprazole after multiple dose
Tmax,ss(Time to maximum plasma concentration at steady state)
Evaluation PK esomeprazole after multiple dose
t1/2,ss(Terminal elimination half-life at steady state)
Evaluation PK esomeprazole after multiple dose
CLss/F(Apparent Clearance at steady state)
Evaluation PK esomeprazole after multiple dose
Vss/F(Apparent Volume of distribution at steady state)
Evaluation PK esomeprazole after multiple dose
PTF(Peak trough fluctuation over one dosing interal at steady state)
Evaluation PK esomeprazole after multiple dose
After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours
Evaluation PD esomeprazole
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
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
Evaluation PD esomeprazole

Full Information

First Posted
June 4, 2019
Last Updated
January 11, 2021
Sponsor
Addpharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03980756
Brief Title
A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole
Official Title
A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-206 to Esomeprazole in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
April 27, 2020 (Actual)
Study Completion Date
June 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A1
Arm Type
Experimental
Arm Description
Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg)
Arm Title
Group A2
Arm Type
Experimental
Arm Description
Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg)
Arm Title
Group B1
Arm Type
Experimental
Arm Description
Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg)
Arm Title
Group B2
Arm Type
Experimental
Arm Description
Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg)
Intervention Type
Drug
Intervention Name(s)
AD-206 20mg
Other Intervention Name(s)
Test drug
Intervention Description
1 tablet administered before the breakfast during 7 days
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 20mg
Other Intervention Name(s)
Reference Drug
Intervention Description
1 tablet administered before the breakfast during 7 days
Intervention Type
Drug
Intervention Name(s)
AD-206 40mg
Other Intervention Name(s)
Test drug
Intervention Description
1 tablet administered before the breakfast during 7 days
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 40mg
Other Intervention Name(s)
Reference Drug
Intervention Description
1 tablet administered before the breakfast during 7 days
Primary Outcome Measure Information:
Title
AUCtau,ss(Area under the plasma drug concentration-time curve)
Description
Evaluation PK esomeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)
Description
Evaluation PD esomeprazole after multiple dose
Time Frame
Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
Secondary Outcome Measure Information:
Title
AUCtau(Area under the plasma drug concentration-time curve)
Description
Evaluation PK esomeprazole after single dose
Time Frame
Day1
Title
Cmax(Maximum concentration of drug in plasma)
Description
Evaluation PK esomeprazole after single dose
Time Frame
Day1
Title
Tmax(Time to maximum plasma concentration)
Description
Evaluation PK esomeprazole after single dose
Time Frame
Day1
Title
t1/2(Terminal elimination half-life)
Description
Evaluation PK esomeprazole after single dose
Time Frame
Day1
Title
CL/F(Apparent clearance)
Description
Evaluation PK esomeprazole after single dose
Time Frame
Day1
Title
Vd/F(Apparent volume of distribution)
Description
Evaluation PK esomeprazole after single dose
Time Frame
Day1
Title
Cmax,ss(Maximum concentration of drug in plasma at steady state)
Description
Evaluation PK esomeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)
Description
Evaluation PK esomeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Cav,ss(Average concentration of drug in plasma at steady state)
Description
Evaluation PK esomeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Tmax,ss(Time to maximum plasma concentration at steady state)
Description
Evaluation PK esomeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
t1/2,ss(Terminal elimination half-life at steady state)
Description
Evaluation PK esomeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
CLss/F(Apparent Clearance at steady state)
Description
Evaluation PK esomeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Vss/F(Apparent Volume of distribution at steady state)
Description
Evaluation PK esomeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
PTF(Peak trough fluctuation over one dosing interal at steady state)
Description
Evaluation PK esomeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours
Description
Evaluation PD esomeprazole
Time Frame
Day1 24hrs pH monitoring
Title
After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours
Description
Evaluation PD esomeprazole
Time Frame
Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
Title
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
Description
Evaluation PD esomeprazole
Time Frame
Day1 24hrs pH monitoring, Day7 24hrs pH monitoring

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Jin Jang, M.D.,Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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