Healthy Volunteer
Conditions
Brief summary
Primary objective - To evaluate food effect on the pharmacokinetics and the pharmacodynamics (PD) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition. Secondary objectives \- To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
Interventions
DRUGHIP1601 40mg
Single dosing of HIP1601 40mg, PO
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Male/Female healthy volunteers in the age between 19 and 50 years old. * Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg. * Helicobacter pylori (H. Pylori) negative. * After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening. * Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
Exclusion criteria
* Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug. * Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to esomeprazole or the same component or other drugs (aspirin, antibiotics, etc.). * Blood serum aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization. * Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay. * Heavy smoker (\>10 cigarettes/day).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Blood sampling during 24 hours after administration | Maximum observed concentration after dose |
| Area Under the plasma concentration versus time Curve(AUC)last | Blood sampling during 24 hours after administration | Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration |
| Integrated gastric acidity for 24-hour | Blood sampling during 24 hours after administration | Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median pH | Blood sampling during 24 hours after administration | Median intra-gastric pH for 24-hour interval after dose |
| Tmax | Blood sampling during 24 hours after administration | Time of Cmax over the time span specified |
| Clearance/F | Blood sampling during 24 hours after administration | Apparent total body clearance after extravascular administration, calculated as Dose/AUCinf |
| t1/2 | Blood sampling during 24 hours after administration | Terminal half-life |
| AUCinf | Blood sampling during 24 hours after administration | Area under the plasma concentration versus time curve from the time of dosing to time extrapolated to infinitely |
| Vd/F | Blood sampling during 24 hours after administration | Apparent volume of distribution after extravascular administration, calculated as Dose/(λzㆍAUCinf) |
| Duration of time intra-gastric pH 4.0 or higher | Blood sampling during 24 hours after administration | Percent of time with intra-gastric pH greater than 4.0 for 24-hour interval after dose |
Countries
South Korea
Outcome results
None listed