NCT03980756

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

A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-206 to Esomeprazole in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Addpharma Inc. · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Gastritis

Interventions

Type	Name	Description
DRUG	AD-206 20mg	1 tablet administered before the breakfast during 7 days
DRUG	Esomeprazole 20mg	1 tablet administered before the breakfast during 7 days
DRUG	AD-206 40mg	1 tablet administered before the breakfast during 7 days
DRUG	Esomeprazole 40mg	1 tablet administered before the breakfast during 7 days

Timeline

• Start date: 2019-06-05
• Primary completion: 2020-04-27
• Completion: 2020-06-18
• First posted: 2019-06-10
• Last updated: 2021-01-13

Locations

1 site across 1 country: South Korea