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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
Sponsor:
Information provided by (Responsible Party):
Addpharma Inc.

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

Condition or disease Intervention/treatment Phase
Gastroesophagus Reflux Disease Drug: AD-213-A Drug: AD-2131 Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. AUCtau [ Time Frame: From Day 1 up to Day 17 ]
    Evaluation PK after multiple dose

  2. Integrated gastric acidity(%Decrease form baseline) [ Time Frame: 4 times from Day -1 to Day 17 ]
    Evaluation PD after multiple dose


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Day 1 ]
    Evaluation PK after single dose

  2. AUClast [ Time Frame: Day 1 ]
    Evaluation PK after single dose

  3. AUCinf [ Time Frame: Day 1 ]
    Evaluation PK after single dose

  4. Tmax [ Time Frame: Day 1 ]
    Evaluation PK after single dose

  5. t1/2 [ Time Frame: Day 1 ]
    Evaluation PK after single dose

  6. CL/F [ Time Frame: Day 1 ]
    Evaluation PK after single dose

  7. Vd/F [ Time Frame: Day 1 ]
    Evaluation PK after single dose

  8. Cmax,ss [ Time Frame: From Day 1 up to Day 17 ]
    Evaluation PK after multiple dose

  9. Cmin,ss [ Time Frame: From Day 1 up to Day 17 ]
    Evaluation PK after multiple dose

  10. AUCinf [ Time Frame: From Day 1 up to Day 17 ]
    Evaluation PK after multiple dose

  11. Tmax,ss [ Time Frame: From Day 1 up to Day 17 ]
    Evaluation PK after multiple dose

  12. t1/2 [ Time Frame: From Day 1 up to Day 17 ]
    Evaluation PK after multiple dose

  13. CLss/F [ Time Frame: From Day 1 up to Day 17 ]
    Evaluation PK after multiple dose

  14. Vdss/F [ Time Frame: From Day 1 up to Day 17 ]
    Evaluation PK after multiple dose

  15. Integrated gastric acidity(Variations form baseline) [ Time Frame: 4 times from Day -1 to Day 17 ]
    Evaluation PD after multiple dose

  16. 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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
Sponsors and Collaborators
Addpharma Inc.
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No