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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04703868

Enrollment

Registered

2021-01-11

Start date

2021-01-13

Completion date

2021-06-14

Last updated

2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

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

Interventions

DRUGRabeprazole Sodium 10mg

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

DRUGRabeprazole Sodium 20mg

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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
AUCt,ss	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose

Secondary

Measure	Time frame	Description
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
Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose	24 hours	Evaluateion PD 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
t1/2,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
Cmin,ss,	From Day 1 up to Day 29	Evaluateion PK 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026