A Study to Compare PK, PD and Safety of the AD-213-A and AD-2131
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ClinicalTrials.gov Identifier: NCT04690868 |
Recruitment Status :
Suspended
(Rescheduled Study)
First Posted : December 31, 2020
Last Update Posted : January 13, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophagus Reflux Disease | Drug: AD-213-A Drug: AD-2131 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Estimated Study Start Date : | February 2021 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | August 2021 |

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

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690868
Korea, Republic of | |
Kyungpook National University Hospital | |
Daegu, Korea, Republic of |
Responsible Party: | Addpharma Inc. |
ClinicalTrials.gov Identifier: | NCT04690868 |
Other Study ID Numbers: |
AD-213PK/PD |
First Posted: | December 31, 2020 Key Record Dates |
Last Update Posted: | January 13, 2021 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |