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

Gastritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980756
• Other study ID #: AD-206PK/PD
• Status: Completed
• Phase: Phase 1
• Start date: June 5, 2019
• Est. completion date: June 18, 2020

Study information

• Verified date: January 2021
• Source: Addpharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 18, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastritis

Intervention

Drug:
• AD-206 20mg
1 tablet administered before the breakfast during 7 days
• Esomeprazole 20mg
1 tablet administered before the breakfast during 7 days
• AD-206 40mg
1 tablet administered before the breakfast during 7 days
• Esomeprazole 40mg
1 tablet administered before the breakfast during 7 days

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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