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Primary objective
- To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
Secondary objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601 |
|
| Sequence 2 | Experimental | Period 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIP1601 40mg | Drug | Single dosing of HIP1601 40mg, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed concentration after dose | Blood sampling during 24 hours after administration |
| Area Under the plasma concentration versus time Curve(AUC)last | Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration | Blood sampling during 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time of Cmax over the time span specified | Blood sampling during 24 hours after administration |
| AUCinf | Area under the plasma concentration versus time curve from the time of dosing to time extrapolated to infinitely |
| Measure | Description | Time Frame |
|---|---|---|
| Integrated gastric acidity for 24-hour | Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose | Blood sampling during 24 hours after administration |
| Duration of time intra-gastric pH 4.0 or higher |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jang In-Jin, MD | Seoul National University Hospital, Seoul, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Biomedical Research Institute | Seoul | South Korea |
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| Blood sampling during 24 hours after administration |
| t1/2 | Terminal half-life | Blood sampling during 24 hours after administration |
| Clearance/F | Apparent total body clearance after extravascular administration, calculated as Dose/AUCinf | Blood sampling during 24 hours after administration |
| Vd/F | Apparent volume of distribution after extravascular administration, calculated as Dose/(λzㆍAUCinf) | Blood sampling during 24 hours after administration |
Percent of time with intra-gastric pH greater than 4.0 for 24-hour interval after dose
| Blood sampling during 24 hours after administration |
| Median pH | Median intra-gastric pH for 24-hour interval after dose | Blood sampling during 24 hours after administration |
| Integrated gastric acidity by time interval | Percent decrease from baseline in integrated gastric acidity after dose by time intervals | Blood sampling during 24 hours after administration |