A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121

January 30, 2024 updated by: Addpharma Inc.

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

Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Seung Hwan Lee, M.D., Ph.D.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Seunghwan Lee, M.D.,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm-A
Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A)
Drug: Lansoprazole 15 mg
AD-2121 (Lansoprazole 15 mg), Oral, Capsule
Drug: Lansoprazole 15mg/Calcium carbonate 600mg
AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet
Experimental: Arm-B
Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121)
Drug: Lansoprazole 15 mg
AD-2121 (Lansoprazole 15 mg), Oral, Capsule
Drug: Lansoprazole 15mg/Calcium carbonate 600mg
AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)
Time Frame: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)
AUCτ,ss after 7days repeated administration of Lansoprazole
pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)
Percent Decrease from baseline of Integrated gastric acidity
Time Frame: 24 hours before 1st administration to 24 hours after repeated administration (7days)

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
24 hours before 1st administration to 24 hours after repeated administration (7days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

June 15, 2024

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 3, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-212PK/PD-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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