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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494243
• Other study ID #: AD-214PK/PD
• Status: Completed
• Phase: Phase 1
• Start date: August 28, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: July 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-214 10/600mg to Rabeprazole 10mg in healthy volunteers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• AD-214 10/600mg
1 tablet administered before the breakfast during 7 days
• Rabeprazole 10mg
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)	Evaluateion PK Rabeprazole 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 Rabeprazole after multiple dose	Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
Secondary	AUCtau(Area under the plasma drug concentration-time curve)	Evaluation PK Rabeprazole after single dose	Day1
Secondary	Cmax(Maximum concentration of drug in plasma)	Evaluation PK Rabeprazole after single dose	Day1
Secondary	Tmax(Time to maximum plasma concentration)	Evaluation PK Rabeprazole after single dose	Day1
Secondary	t1/2(Terminal elimination half-life)	Evaluation PK Rabeprazole after single dose	Day1
Secondary	CL/F(Apparent clearance)	Evaluation PK Rabeprazole after single dose	Day1
Secondary	Vd/F(Apparent volume of distribution)	Evaluation PK Rabeprazole after single dose	Day1
Secondary	Cmax,ss(Maximum concentration of drug in plasma at steady state)	Evaluation PK Rabeprazole 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 Rabeprazole after multiple dose	From Day 1 up to Day 29
Secondary	Cav,ss(Average concentration of drug in plasma at steady state)	Evaluation PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Secondary	Tmax,ss(Time to maximum plasma concentration at steady state)	Evaluation PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Secondary	t1/2,ss(Terminal elimination half-life at steady state)	Evaluation PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Secondary	CLss/F(Apparent Clearance at steady state)	Evaluation PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Secondary	Vss/F(Apparent Volume of distribution at steady state)	Evaluation PK Rabeprazole after multiple dose	From Day 1 up to Day 29
Secondary	PTF(Peak trough fluctuation over one dosing interal at steady state)	Evaluation PK Rabeprazole 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 Rabeoprazoke	Day1 24hours 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 Rabeoprazoke	Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
Secondary	After the first administration and 7 days of repeated administration, The median pH measured for 24 hours	Evaluation PD Rabeoprazoke	Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring