Clinical trial NCT03980756: A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastritis
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-10
Enrollment: 88
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: AUCtau,ss(Area under the plasma drug concentration-time curve)
timeFrame: From Day 1 up to Day 29
measure: Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)
timeFrame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
Secondary outcomes:
measure: AUCtau(Area under the plasma drug concentration-time curve)
timeFrame: Day1
measure: Cmax(Maximum concentration of drug in plasma)
timeFrame: Day1
measure: Tmax(Time to maximum plasma concentration)
timeFrame: Day1
measure: t1/2(Terminal elimination half-life)
timeFrame: Day1
measure: CL/F(Apparent clearance)
timeFrame: Day1
measure: Vd/F(Apparent volume of distribution)
timeFrame: Day1
measure: Cmax,ss(Maximum concentration of drug in plasma at steady state)
timeFrame: From Day 1 up to Day 29
measure: Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)
timeFrame: From Day 1 up to Day 29
measure: Cav,ss(Average concentration of drug in plasma at steady state)
timeFrame: From Day 1 up to Day 29
measure: Tmax,ss(Time to maximum plasma concentration at steady state)
timeFrame: From Day 1 up to Day 29
measure: t1/2,ss(Terminal elimination half-life at steady state)
timeFrame: From Day 1 up to Day 29
measure: CLss/F(Apparent Clearance at steady state)
timeFrame: From Day 1 up to Day 29
measure: Vss/F(Apparent Volume of distribution at steady state)
timeFrame: From Day 1 up to Day 29
measure: PTF(Peak trough fluctuation over one dosing interal at steady state)
timeFrame: From Day 1 up to Day 29
measure: After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours
timeFrame: Day1 24hrs pH monitoring
measure: After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours
timeFrame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
measure: After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
timeFrame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: