A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole

Addpharma

Status and phase: Completed; Phase 1

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: AD-214 10/600mg; Drug: Rabeprazole 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04494243

AD-214PK/PD

Details and patient eligibility

About

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in healthy volunteers.

Full description

This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214 10/600mg compared with administration of Rabeprazole 10mg in healthy volunteers.

Enrollment: 40 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 19~50 years in healthy volunteers
• BMI is more than 18.0 kg/m^2 , no more than 27.0 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 judged ineligible by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

AD-214/Rabeprazole

Experimental group

Description:

Period 1 : Test Drug(AD-214 10/600mg) Period 2 : Reference Drug(Rabeprazole 10mg)

Treatment:

Drug: Rabeprazole 10mg

Drug: AD-214 10/600mg

Rabeprazole/AD-214

Experimental group

Description:

Period 1 : Reference Drug(Rabeprazole 10mg) Period 2 : Test Drug(AD-214 10/600mg)

Treatment:

Drug: Rabeprazole 10mg

Drug: AD-214 10/600mg