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Completed

NCT Number: NCT04622358

A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214-02 to Rabeprazole in healthy volunteers.

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Key information

Conditions

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

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214-02 compared with administration of Rabeprazole in healthy volunteers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 19~50 years in healthy volunteers
  • BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^2
  • Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion criteria

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
  • Subjects who judged ineligible by the investigator

Treatment and study plan

AD-214-02

Drug

1 tablet administered before the breakfast during 7 days

rabeprazole

Drug

1 tablet administered before the breakfast during 7 days

Primary outcomes

  1. AUCtau,ss(Area under the plasma drug concentration-time curve)

    Time frame: From Day 1 up to Day 29

    Evaluation PK Rabeprazole after multiple dose

  2. Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)

    Time frame: Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring

    Evaluation PD Rabeprazole after multiple dose

Secondary outcomes

  1. AUCtau(Area under the plasma drug concentration-time curve)

    Time frame: Day1

    Evaluation PK Rabeprazole after single dose

  2. Cmax(Maximum concentration of drug in plasma)

    Time frame: Day1

    Evaluation PK Rabeprazole after single dose

  3. Tmax(Time to maximum plasma concentration)

    Time frame: Day1

    Evaluation PK Rabeprazole after single dose

  4. t1/2(Terminal elimination half-life)

    Time frame: Day1

    Evaluation PK Rabeprazole after single dose

  5. Cmax,ss(Maximum concentration of drug in plasma at steady state)

    Time frame: From Day 1 up to Day 29

    Evaluation PK Rabeprazole after multiple dose

  6. Tmax,ss(Time to maximum plasma concentration at steady state)

    Time frame: From Day 1 up to Day 29

    Evaluation PK Rabeprazole after multiple dose

  7. t1/2,ss(Terminal elimination half-life at steady state)

    Time frame: From Day 1 up to Day 29

    Evaluation PK Rabeprazole after multiple dose

  8. After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours

    Time frame: Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring

    Evaluation PD Rabeoprazoke

  9. After the first administration and 7 days of repeated administration, The median pH measured for 24 hours

    Time frame: Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring

    Evaluation PD Rabeoprazoke

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-214-02 to Rabeprazole in Healthy Volunteers

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 10, 2020
Registry last updated
Jul 21, 2021

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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