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

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

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

Study Overview

• Status: Completed
• Conditions: Gastroesophagus Reflux Disease
• Intervention / Treatment: Drug: AD-213-A; Drug: AD-2131

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCtau	Evaluation PK after multiple dose	From Day 1 up to Day 17
Integrated gastric acidity(%Decrease form baseline)	Evaluation PD after multiple dose	4 times from Day -1 to Day 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Evaluation PK after single dose	Day 1
AUClast	Evaluation PK after single dose	Day 1
AUCinf	Evaluation PK after single dose	Day 1
Tmax	Evaluation PK after single dose	Day 1
t1/2	Evaluation PK after single dose	Day 1
CL/F	Evaluation PK after single dose	Day 1
Vd/F	Evaluation PK after single dose	Day 1
Percentage of time to maintain gastric pH 4.0 or higher	Evaluation PD after multiple dose	4 times from Day -1 to Day 17
Cmax,ss	Evaluation PK after multiple dose	From Day 1 up to Day 17
Cmin,ss	Evaluation PK after multiple dose	From Day 1 up to Day 17
AUCinf	Evaluation PK after multiple dose	From Day 1 up to Day 17
Tmax,ss	Evaluation PK after multiple dose	From Day 1 up to Day 17
t1/2	Evaluation PK after multiple dose	From Day 1 up to Day 17
CLss/F	Evaluation PK after multiple dose	From Day 1 up to Day 17
Vdss/F	Evaluation PK after multiple dose	From Day 1 up to Day 17
Integrated gastric acidity(Variations form baseline)	Evaluation PD after multiple dose	4 times from Day -1 to Day 17

Collaborators and Investigators

• Sponsor: Addpharma Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2021
• Primary Completion (ACTUAL): December 11, 2021
• Study Completion (ACTUAL): December 21, 2021

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 27, 2020
• First Posted (ACTUAL): December 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: AD-213PK/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