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Completed

NCT Number: NCT04703868

A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects

A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

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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–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, Daehak-ro Jongno-gu, 110-744, South Korea

About this study

This study is to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 19~55 years in healthy volunteers
  • BMI is more than 18.0 kg/m^2 , no more than 28.0 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 were judged ineligible by the investigator

Treatment and study plan

Rabeprazole Sodium 10mg

Drug

Part A: 1 tablet administered before the breakfast during 7 days

Other names: Reference drug

Rabeprazole Sodium 20mg

Drug

Part B: 1 tablet administered before the breakfast during 7 days

Other names: Reference drug

Primary outcomes

  1. Integrated gastric acidity

    Time frame: From Day 1 up to Day 28

    Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose

  2. AUCt,ss

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

Secondary outcomes

  1. Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose

    Time frame: 24 hours

    Evaluateion PD Rabeprazole after multiple dose

  2. Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th dose

    Time frame: From Day 1 up to Day 28

    Evaluateion PD Rabeprazole after multiple dose

  3. Mean and median gastric pH after 1st and 7th dose

    Time frame: From Day 1 up to Day 28

    Evaluateion PD Rabeprazole after multiple dose

  4. AUCτ

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  5. Cmax

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  6. Tmax

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  7. t1/2

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  8. CL/F

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  9. Vz/F

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  10. Cmin,ss,

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  11. Cmax,ss

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  12. Cav,ss,

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  13. Tmax,ss

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  14. t1/2,ss

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  15. CLss/F

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

  16. Vss/F

    Time frame: From Day 1 up to Day 29

    Evaluateion PK Rabeprazole after multiple dose

Sponsors and collaborators

Lead sponsor

Yungjin Pharm. Co., Ltd.

Industry

Collaborators

  • Seoul National University Hospital

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2021
Registry last updated
Jan 24, 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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