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

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: Rabeprazole Sodium 10mg; Drug: Rabeprazole Sodium 20mg

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

• Study Contact: Name: Yungjin Pharm; Phone Number: 82-2-2041-8325; Email: dhkwon1201@yungjin.co.kr

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YPI-011 10/500mg; Part A: 1 tablet administered before the breakfast during 7 days	Drug: Rabeprazole Sodium 10mg; 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	Drug: Rabeprazole Sodium 20mg; 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	Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose	From Day 1 up to Day 28
AUCt,ss	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	Evaluateion PD Rabeprazole after multiple dose	24 hours
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
Mean and median gastric pH after 1st and 7th dose	Evaluateion PD Rabeprazole after multiple dose	From Day 1 up to Day 28
AUCτ	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Cmax	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Tmax	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
t1/2	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
CL/F	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Vz/F	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Cmin,ss,	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Cmax,ss	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Cav,ss,	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Tmax,ss	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
t1/2,ss	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
CLss/F	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Vss/F	Evaluateion PK Rabeprazole after multiple dose	From Day 1 up to Day 29

Collaborators and Investigators

• Sponsor: Yungjin Pharm. Co., Ltd.
• Collaborators: Seoul National University Hospital
• Investigators: Principal Investigator: Seunghwan Lee, M.D., Ph.D, Seoul National University Hospital

Study record dates

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

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: YJ26-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No