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NCT04703868 Clinical Trial

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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04703868
Other study ID # YJ26-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 13, 2021
Est. completion date June 14, 2021

Study information
Verified date January 2024
Source Yungjin Pharm. Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date June 14, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rabeprazole Sodium 10mg
Part A: 1 tablet administered before the breakfast during 7 days
• Rabeprazole Sodium 20mg
Part B: 1 tablet administered before the breakfast during 7 days

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Daehak-ro Jongno-gu

Sponsors (2)
Lead Sponsor Collaborator
Yungjin Pharm. Co., Ltd. Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Integrated gastric acidity Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose From Day 1 up to Day 28
Primary AUCt,ss Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose Evaluateion PD Rabeprazole after multiple dose 24 hours
Secondary Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th dose Evaluateion PD Rabeprazole after multiple dose From Day 1 up to Day 28
Secondary Mean and median gastric pH after 1st and 7th dose Evaluateion PD Rabeprazole after multiple dose From Day 1 up to Day 28
Secondary AUCt Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Cmax Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Tmax Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary t1/2 Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary CL/F Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Vz/F Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Cmin,ss, Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Cmax,ss Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Cav,ss, Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Tmax,ss Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary t1/2,ss Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary CLss/F Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
Secondary Vss/F Evaluateion PK Rabeprazole after multiple dose From Day 1 up to Day 29
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