Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations
- Registration Number
- NCT03372850
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 96
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence Group 1 HGP1705 Period 1: Reference Drug(HGP1705) Period 2: Test Drug(HIP1601) Sequence Group 1 HIP1601 Period 1: Reference Drug(HGP1705) Period 2: Test Drug(HIP1601) Sequence Group 2 HGP1705 Period 1: Test Drug(HIP1601) Period 2: Reference Drug(HGP1705) Sequence Group 2 HIP1601 Period 1: Test Drug(HIP1601) Period 2: Reference Drug(HGP1705)
- Primary Outcome Measures
Name Time Method 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
After 7days of repeated administration, Total gastric acidity decrease rate versus baseline for 24 hours 7Day 24h(Full time) pH monitoring pharmacodynamic evaluation
- Secondary Outcome Measures
Name Time Method 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
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
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
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, The median pH measured between 12hours and 24 hours 1Day (12~24h) pH monitoring, 7Day (12~24h) pH monitoring pharmacodynamic 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
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
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
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
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
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
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
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 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 between 12hours and 24 hours 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h pharmacodynamic evaluation
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of