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

January 22, 2024 updated by: Yungjin Pharm. Co., Ltd.
A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

Study Overview

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

88

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 Locations

    • Daehak-ro Jongno-gu
      • Seoul, Daehak-ro Jongno-gu, Korea, Republic of, 110-744
        • Seoul National University Hospital

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

19 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: YPI-011 10/500mg
Part A: 1 tablet administered before the breakfast during 7 days
Part A: 1 tablet administered before the breakfast during 7 days
Other Names:
  • Reference drug
Experimental: YPI-011 20/500mg
Part B: 1 tablet administered before the breakfast during 7 days
Part B: 1 tablet administered before the breakfast during 7 days
Other Names:
  • Reference drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From Day 1 up to Day 28
AUCt,ss
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours
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
From Day 1 up to Day 28
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
From Day 1 up to Day 28
AUCτ
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
Cmax
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
Tmax
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
t1/2
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
CL/F
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
Vz/F
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
Cmin,ss,
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
Cmax,ss
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
Cav,ss,
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
Tmax,ss
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
t1/2,ss
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
CLss/F
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29
Vss/F
Time Frame: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
From Day 1 up to Day 29

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Seunghwan Lee, M.D., Ph.D, Seoul National University Hospital

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)

January 13, 2021

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 14, 2021

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

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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