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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rabeprazole Sodium 10mg
Rabeprazole Sodium 20mg
Sponsored by
Yungjin Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

YPI-011 10/500mg

YPI-011 20/500mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

Integrated gastric acidity
Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose
AUCt,ss
Evaluateion PK Rabeprazole after multiple dose

Secondary Outcome Measures

Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose
Evaluateion PD Rabeprazole after multiple dose
Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th dose
Evaluateion PD Rabeprazole after multiple dose
Mean and median gastric pH after 1st and 7th dose
Evaluateion PD Rabeprazole after multiple dose
AUCτ
Evaluateion PK Rabeprazole after multiple dose
Cmax
Evaluateion PK Rabeprazole after multiple dose
Tmax
Evaluateion PK Rabeprazole after multiple dose
t1/2
Evaluateion PK Rabeprazole after multiple dose
CL/F
Evaluateion PK Rabeprazole after multiple dose
Vz/F
Evaluateion PK Rabeprazole after multiple dose
Cmin,ss,
Evaluateion PK Rabeprazole after multiple dose
Cmax,ss
Evaluateion PK Rabeprazole after multiple dose
Cav,ss,
Evaluateion PK Rabeprazole after multiple dose
Tmax,ss
Evaluateion PK Rabeprazole after multiple dose
t1/2,ss
Evaluateion PK Rabeprazole after multiple dose
CLss/F
Evaluateion PK Rabeprazole after multiple dose
Vss/F
Evaluateion PK Rabeprazole after multiple dose

Full Information

First Posted
January 7, 2021
Last Updated
June 25, 2021
Sponsor
Yungjin Pharm. Co., Ltd.
Collaborators
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04703868
Brief Title
A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects
Official Title
A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yungjin Pharm. Co., Ltd.
Collaborators
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects
Detailed Description
This study is to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
YPI-011 10/500mg
Arm Type
Experimental
Arm Description
Part A: 1 tablet administered before the breakfast during 7 days
Arm Title
YPI-011 20/500mg
Arm Type
Experimental
Arm Description
Part B: 1 tablet administered before the breakfast during 7 days
Intervention Type
Drug
Intervention Name(s)
Rabeprazole Sodium 10mg
Other Intervention Name(s)
Reference drug
Intervention Description
Part A: 1 tablet administered before the breakfast during 7 days
Intervention Type
Drug
Intervention Name(s)
Rabeprazole Sodium 20mg
Other Intervention Name(s)
Reference drug
Intervention Description
Part B: 1 tablet administered before the breakfast during 7 days
Primary Outcome Measure Information:
Title
Integrated gastric acidity
Description
Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose
Time Frame
From Day 1 up to Day 28
Title
AUCt,ss
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Secondary Outcome Measure Information:
Title
Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose
Description
Evaluateion PD Rabeprazole after multiple dose
Time Frame
24 hours
Title
Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th dose
Description
Evaluateion PD Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 28
Title
Mean and median gastric pH after 1st and 7th dose
Description
Evaluateion PD Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 28
Title
AUCτ
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Cmax
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Tmax
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
t1/2
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
CL/F
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Vz/F
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Cmin,ss,
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Cmax,ss
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Cav,ss,
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Tmax,ss
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
t1/2,ss
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
CLss/F
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Vss/F
Description
Evaluateion PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yungjin Pharm
Phone
82-2-2041-8325
Email
dhkwon1201@yungjin.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seunghwan Lee, M.D., Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Daehak-ro Jongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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