A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole

Addpharma

Status and phase: Completed; Phase 1

Conditions: Gastritis

Treatments: Drug: Esomeprazole 20mg; Drug: AD-206 40mg; Drug: Esomeprazole 40mg; Drug: AD-206 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03980756

AD-206PK/PD

Details and patient eligibility

About

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.

Full description

This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of AD-206 compared with administration of Esomeprazole in healthy male subjects.

Enrollment: 88 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 19~50 years in healthy male volunteers
• BMI is more than 18 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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88 participants in 4 patient groups

Group A1

Experimental group

Description:

Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg)

Treatment:

Drug: AD-206 20mg

Drug: Esomeprazole 20mg

Group A2

Experimental group

Description:

Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg)

Treatment:

Drug: AD-206 20mg

Drug: Esomeprazole 20mg

Group B1

Experimental group

Description:

Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg)

Treatment:

Drug: Esomeprazole 40mg

Drug: AD-206 40mg

Group B2

Experimental group

Description:

Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg)

Treatment:

Drug: Esomeprazole 40mg

Drug: AD-206 40mg