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

Phase 1

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Rabeprazole Sodium 10mg; Drug: Rabeprazole Sodium 20mg

• Registration Number: NCT04703868
• Lead Sponsor: Yungjin Pharm. Co., Ltd.

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

Study Timeline

• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-11
• Study Start: 2021-01-13
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
YPI-011 10/500mg	Rabeprazole Sodium 10mg	Part A: 1 tablet administered before the breakfast during 7 days
YPI-011 20/500mg	Rabeprazole Sodium 20mg	Part B: 1 tablet administered before the breakfast during 7 days

Primary Outcome Measures

Name	Time	Method
AUCt,ss	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
Integrated gastric acidity	From Day 1 up to Day 28	Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose

Secondary Outcome Measures

Name	Time	Method
Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose	24 hours	Evaluateion PD Rabeprazole after multiple dose
Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th dose	From Day 1 up to Day 28	Evaluateion PD Rabeprazole after multiple dose
Mean and median gastric pH after 1st and 7th dose	From Day 1 up to Day 28	Evaluateion PD Rabeprazole after multiple dose
AUCτ	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
Cmax	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
Tmax	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
t1/2	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
CL/F	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
Vz/F	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
Cmin,ss,	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
Cmax,ss	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
Cav,ss,	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
Tmax,ss	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
CLss/F	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
Vss/F	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
t1/2,ss	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Daehak-ro Jongno-gu, Korea, Republic of