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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2021-06-14

Brief Summary

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

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Detailed Description

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

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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YPI-011 10/500mg

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

Group Type EXPERIMENTAL

Rabeprazole Sodium 10mg

Intervention Type DRUG

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

YPI-011 20/500mg

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

Group Type EXPERIMENTAL

Rabeprazole Sodium 20mg

Intervention Type DRUG

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

Interventions

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Rabeprazole Sodium 10mg

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

Intervention Type DRUG

Rabeprazole Sodium 20mg

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

Intervention Type DRUG

Other Intervention Names

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Reference drug Reference drug

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes