Healthy
Conditions
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.
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| After 7days of repeated administration, Total gastric acidity decrease rate versus baseline for 24 hours | 7Day 24h(Full time) pH monitoring | pharmacodynamic evaluation |
| AUClast of esomeprazole | 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 | pharmacokinetic evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vd/F of esomeprazole | 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 | pharmacokinetic evaluation |
| AUCinf of esomeprazole | 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 | pharmacokinetic evaluation |
| Cmax of esomeprazole | 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 | pharmacokinetic evaluation |
| Tmax of esomeprazole | 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 | pharmacokinetic evaluation |
| Terminal Half-life of esomeprazole | 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 | pharmacokinetic evaluation |
| Ctrough | 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 | pharmacokinetic evaluation |
| Ctrough,ss | 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 | pharmacokinetic evaluation |
| RActrough | 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 | pharmacokinetic evaluation |
| After the first administration of esomeprazole, The rate of decrease of integrated gastric acidity compared to baseline for 24 hours | 1Day 24h pH monitoring | pharmacodynamic evaluation |
| After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours | 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring | pharmacodynamic evaluation |
| After the first administration and 7 days of repeated administration, The median pH measured for 24 hours | 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring | pharmacodynamic evaluation |
| After first administration and 7 days of repeated administration, Total gastric acidity reduction rate versus baseline between 12hours and 24 hours | 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h | pharmacodynamic evaluation |
| 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 | 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h | pharmacodynamic evaluation |
| After the first dose and 7 days of repeated dosing, The median pH measured between 12hours and 24 hours | 1Day (12~24h) pH monitoring, 7Day (12~24h) pH monitoring | pharmacodynamic evaluation |
| PTF | 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 | pharmacokinetic evaluation |
| CL/F of esomeprazole | 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 | pharmacokinetic evaluation |
Other
| Measure | Time frame | Description |
|---|---|---|
| After first administration and repeated administration for 7 days, The percentage of decrease in integrated gastric acidity compared to baseline by time | 1Day(Full time) pH monitoring, 7Day 24h (Full time) pH monitoring | exploratory endpoint |
Countries
South Korea
Contacts
Primary ContactSujin Kim, Pharm.D.
Outcome results
None listed