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Completed

NCT Number: NCT06025773

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

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

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Key information

Conditions

Gastro Esophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lansoprazole 15 mg

Drug

AD-2121 (Lansoprazole 15 mg), Oral, Capsule

Lansoprazole 15mg/Calcium carbonate 600mg

Drug

AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 6, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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