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

Yungjin Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Rabeprazole Sodium 20mg; Drug: Rabeprazole Sodium 10mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04703868

YJ26-101

Details and patient eligibility

About

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

Full description

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

Enrollment: 88 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

YPI-011 10/500mg

Experimental group

Description:

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

Treatment:

Drug: Rabeprazole Sodium 10mg

YPI-011 20/500mg

Experimental group

Description:

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

Treatment:

Drug: Rabeprazole Sodium 20mg