Clinical trial NCT03372850: Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations
Official title: A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2017-12-14
Enrollment: 96
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers

Detailed description: This study is a 2-part study, where in Part A, the 40 mg dose will be performed followed by the 20 mg dose in Part B.

Eligibility criteria: Inclusion Criteria:

1. Age 19\~50 years in healthy male volunteers
2. BMI is more than 18 kg/m\^2 , no more than 27.0 kg/m\^2
3. 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:

1. 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
2. Subjects who judged ineligible by the investigator

Primary outcomes:
measure: AUClast of esomeprazole
timeFrame: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
measure: After 7days of repeated administration, Total gastric acidity decrease rate versus baseline for 24 hours
timeFrame: 7Day 24h(Full time) pH monitoring
Secondary outcomes:
measure: AUCinf of esomeprazole
timeFrame: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
measure: Cmax of esomeprazole
timeFrame: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
measure: Tmax of esomeprazole
timeFrame: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
measure: Terminal Half-life of esomeprazole
timeFrame: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
measure: CL/F of esomeprazole
timeFrame: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
measure: Vd/F of esomeprazole
timeFrame: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
measure: Ctrough
timeFrame: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 51 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 2 Day 0 hour
measure: Ctrough,ss
timeFrame: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
measure: PTF
timeFrame: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
measure: RActrough
timeFrame: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
measure: After the first administration of esomeprazole, The rate of decrease of integrated gastric acidity compared to baseline for 24 hours
timeFrame: 1Day 24h 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: 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring
measure: After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
timeFrame: 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring
measure: After first administration and 7 days of repeated administration, Total gastric acidity reduction rate versus baseline between 12hours and 24 hours
timeFrame: 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h
measure: After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher between 12hours and 24 hours
timeFrame: 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h
measure: After the first dose and 7 days of repeated dosing, The median pH measured between 12hours and 24 hours
timeFrame: 1Day (12~24h) pH monitoring, 7Day (12~24h) pH monitoring
Other outcomes:
measure: After first administration and repeated administration for 7 days, The percentage of decrease in integrated gastric acidity compared to baseline by time
timeFrame: 1Day(Full time) pH monitoring, 7Day 24h (Full time) pH monitoring
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: