Back to resultsA Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121
Primary Purpose
Gastro Esophageal Reflux
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lansoprazole 15 mg
Lansoprazole 15mg/Calcium carbonate 600mg
Sponsored by
About this trial
This is an interventional treatment trial for Gastro Esophageal Reflux
Eligibility Criteria
Inclusion Criteria: Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit The Age equal to or greater than 19 in healthy volunteers at the time of screening visit Negative result from Serum Helicobacter pylori antibody at the time of screening visit Exclusion Criteria: Patients with trouble performing Gastric pH monitoring
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm-A
Arm-B
Arm Description
Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A)
Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121)
Outcomes
Primary Outcome Measures
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)
AUCτ,ss after 7days repeated administration of Lansoprazole
Percent Decrease from baseline of Integrated gastric acidity
Percent Decrease from baseline of Integrated gastric acidity after repeated adadministration of Lansoprazole
Integrated gastric acidity calculation:
(Integrated gastric acidity Before - Integrated gastric acidity after)/Integrated gastric acidity Before*100
Acid concentration (mM) = 1000 ⅹ 10-pH
Acidity (mmol.h/L) = (acid in mM at time 't' + acid in mM at time 't-1')/2 ⅹ (t-(t-1))
Integrated Acidity means cumulative sum per second for 24 hours
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06025773
Brief Title
A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121
Official Title
A Randomized, Open-label, 2x2 Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of AD-212-A or AD-2121 in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 8, 2023 (Anticipated)
Primary Completion Date
November 14, 2023 (Anticipated)
Study Completion Date
November 29, 2023 (Anticipated)
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
5. Study Description
Brief Summary
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.
Detailed Description
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-212-A compared with AD-2121 in healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm-A
Arm Type
Experimental
Arm Description
Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A)
Arm Title
Arm-B
Arm Type
Experimental
Arm Description
Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121)
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 15 mg
Intervention Description
AD-2121 (Lansoprazole 15 mg), Oral, Capsule
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 15mg/Calcium carbonate 600mg
Intervention Description
AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet
Primary Outcome Measure Information:
Title
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)
Description
AUCτ,ss after 7days repeated administration of Lansoprazole
Time Frame
pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)
Title
Percent Decrease from baseline of Integrated gastric acidity
Description
Percent Decrease from baseline of Integrated gastric acidity after repeated adadministration of Lansoprazole
Integrated gastric acidity calculation:
(Integrated gastric acidity Before - Integrated gastric acidity after)/Integrated gastric acidity Before*100
Acid concentration (mM) = 1000 ⅹ 10-pH
Acidity (mmol.h/L) = (acid in mM at time 't' + acid in mM at time 't-1')/2 ⅹ (t-(t-1))
Integrated Acidity means cumulative sum per second for 24 hours
Time Frame
24 hours before 1st administration to 24 hours after repeated administration (7days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit
The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
Negative result from Serum Helicobacter pylori antibody at the time of screening visit
Exclusion Criteria:
Patients with trouble performing Gastric pH monitoring
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong Eun Park
Phone
+82-31-891-6989
Email
parkje@addpharma.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Hwan Lee, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121
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