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

Phase 1

Completed

• Conditions: Gastritis
• Interventions: Drug: AD-206 20mg; Drug: AD-206 40mg; Drug: Esomeprazole 20mg; Drug: Esomeprazole 40mg

• Registration Number: NCT03980756
• Lead Sponsor: Addpharma Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2019-06-04
• Study Start: 2019-06-05
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-10
• Primary Completion: 2020-04-27
• Study Completion: 2020-06-18
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 88

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A2	Esomeprazole 20mg	Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg)
Group A1	Esomeprazole 20mg	Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg)
Group B2	Esomeprazole 40mg	Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg)
Group A1	AD-206 20mg	Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg)
Group A2	AD-206 20mg	Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg)
Group B1	AD-206 40mg	Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg)
Group B1	Esomeprazole 40mg	Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg)
Group B2	AD-206 40mg	Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg)

Primary Outcome Measures

Name	Time	Method
AUCtau,ss(Area under the plasma drug concentration-time curve)	From Day 1 up to Day 29	Evaluation PK esomeprazole after multiple dose
Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)	Day1 24hrs pH monitoring, Day7 24hrs pH monitoring	Evaluation PD esomeprazole after multiple dose

Secondary Outcome Measures

Name	Time	Method
PTF(Peak trough fluctuation over one dosing interal at steady state)	From Day 1 up to Day 29	Evaluation PK esomeprazole after multiple dose
AUCtau(Area under the plasma drug concentration-time curve)	Day1	Evaluation PK esomeprazole after single dose
Cmax(Maximum concentration of drug in plasma)	Day1	Evaluation PK esomeprazole after single dose
Tmax(Time to maximum plasma concentration)	Day1	Evaluation PK esomeprazole after single dose
t1/2(Terminal elimination half-life)	Day1	Evaluation PK esomeprazole after single dose
CL/F(Apparent clearance)	Day1	Evaluation PK esomeprazole after single dose
Vd/F(Apparent volume of distribution)	Day1	Evaluation PK esomeprazole after single dose
Cmax,ss(Maximum concentration of drug in plasma at steady state)	From Day 1 up to Day 29	Evaluation PK esomeprazole after multiple dose
Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)	From Day 1 up to Day 29	Evaluation PK esomeprazole after multiple dose
Cav,ss(Average concentration of drug in plasma at steady state)	From Day 1 up to Day 29	Evaluation PK esomeprazole after multiple dose
Tmax,ss(Time to maximum plasma concentration at steady state)	From Day 1 up to Day 29	Evaluation PK esomeprazole after multiple dose
t1/2,ss(Terminal elimination half-life at steady state)	From Day 1 up to Day 29	Evaluation PK esomeprazole after multiple dose
CLss/F(Apparent Clearance at steady state)	From Day 1 up to Day 29	Evaluation PK esomeprazole after multiple dose
Vss/F(Apparent Volume of distribution at steady state)	From Day 1 up to Day 29	Evaluation PK esomeprazole after multiple dose
After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours	Day1 24hrs pH monitoring	Evaluation PD esomeprazole
After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours	Day1 24hrs pH monitoring, Day7 24hrs pH monitoring	Evaluation PD esomeprazole
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours	Day1 24hrs pH monitoring, Day7 24hrs pH monitoring	Evaluation PD esomeprazole

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of