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A Study to Compare PK, PD and Safety of the AD-213-A and AD-2131

Primary Purpose

Gastroesophagus Reflux Disease

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-213-A
AD-2131
Sponsored by
Addpharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophagus Reflux Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults over 19 years of age.
  • Weight is more than 50kg and BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^2.
  • Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials.
  • Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.

Exclusion Criteria:

  • A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug.
  • As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range.
  • As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min.
  • Subjects who judged ineligible by the investigator.

Sites / Locations

  • Kyungpook National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ARM 1

ARM 2

Arm Description

Period 1 : Reference Drug(AD-2131) Period 2 : Test Drug(AD-213-A)

Period 1 : Test Drug(AD-213-A) Period 2 : Reference Drug(AD-2131)

Outcomes

Primary Outcome Measures

AUCtau
Evaluation PK after multiple dose
Integrated gastric acidity(%Decrease form baseline)
Evaluation PD after multiple dose

Secondary Outcome Measures

Cmax
Evaluation PK after single dose
AUClast
Evaluation PK after single dose
AUCinf
Evaluation PK after single dose
Tmax
Evaluation PK after single dose
t1/2
Evaluation PK after single dose
CL/F
Evaluation PK after single dose
Vd/F
Evaluation PK after single dose
Cmax,ss
Evaluation PK after multiple dose
Cmin,ss
Evaluation PK after multiple dose
AUCinf
Evaluation PK after multiple dose
Tmax,ss
Evaluation PK after multiple dose
t1/2
Evaluation PK after multiple dose
CLss/F
Evaluation PK after multiple dose
Vdss/F
Evaluation PK after multiple dose
Integrated gastric acidity(Variations form baseline)
Evaluation PD after multiple dose
Percentage of time to maintain gastric pH 4.0 or higher
Evaluation PD after multiple dose

Full Information

First Posted
December 22, 2020
Last Updated
April 25, 2022
Sponsor
Addpharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04690868
Brief Title
A Study to Compare PK, PD and Safety of the AD-213-A and AD-2131
Official Title
A Randomized, Open Label, Multi Dose, Cross Over Design Clinical Study to Evaluate the Pharmacokinetic Pharmacodynamic Characteristics and Safety of AD-213-A and AD-2131 After Oral Administration in Healthy Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
December 11, 2021 (Actual)
Study Completion Date
December 21, 2021 (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
Yes

5. Study Description

Brief Summary
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ARM 1
Arm Type
Experimental
Arm Description
Period 1 : Reference Drug(AD-2131) Period 2 : Test Drug(AD-213-A)
Arm Title
ARM 2
Arm Type
Experimental
Arm Description
Period 1 : Test Drug(AD-213-A) Period 2 : Reference Drug(AD-2131)
Intervention Type
Drug
Intervention Name(s)
AD-213-A
Intervention Description
1 tablet administered before the breakfast during 5 days
Intervention Type
Drug
Intervention Name(s)
AD-2131
Intervention Description
1 tablet administered before the breakfast during 5 days
Primary Outcome Measure Information:
Title
AUCtau
Description
Evaluation PK after multiple dose
Time Frame
From Day 1 up to Day 17
Title
Integrated gastric acidity(%Decrease form baseline)
Description
Evaluation PD after multiple dose
Time Frame
4 times from Day -1 to Day 17
Secondary Outcome Measure Information:
Title
Cmax
Description
Evaluation PK after single dose
Time Frame
Day 1
Title
AUClast
Description
Evaluation PK after single dose
Time Frame
Day 1
Title
AUCinf
Description
Evaluation PK after single dose
Time Frame
Day 1
Title
Tmax
Description
Evaluation PK after single dose
Time Frame
Day 1
Title
t1/2
Description
Evaluation PK after single dose
Time Frame
Day 1
Title
CL/F
Description
Evaluation PK after single dose
Time Frame
Day 1
Title
Vd/F
Description
Evaluation PK after single dose
Time Frame
Day 1
Title
Cmax,ss
Description
Evaluation PK after multiple dose
Time Frame
From Day 1 up to Day 17
Title
Cmin,ss
Description
Evaluation PK after multiple dose
Time Frame
From Day 1 up to Day 17
Title
AUCinf
Description
Evaluation PK after multiple dose
Time Frame
From Day 1 up to Day 17
Title
Tmax,ss
Description
Evaluation PK after multiple dose
Time Frame
From Day 1 up to Day 17
Title
t1/2
Description
Evaluation PK after multiple dose
Time Frame
From Day 1 up to Day 17
Title
CLss/F
Description
Evaluation PK after multiple dose
Time Frame
From Day 1 up to Day 17
Title
Vdss/F
Description
Evaluation PK after multiple dose
Time Frame
From Day 1 up to Day 17
Title
Integrated gastric acidity(Variations form baseline)
Description
Evaluation PD after multiple dose
Time Frame
4 times from Day -1 to Day 17
Title
Percentage of time to maintain gastric pH 4.0 or higher
Description
Evaluation PD after multiple dose
Time Frame
4 times from Day -1 to Day 17

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults over 19 years of age. Weight is more than 50kg and BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^2. Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials. Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing. Exclusion Criteria: A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug. As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range. As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min. Subjects who judged ineligible by the investigator.
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
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-213-A and AD-2131

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