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This clinical trial is a phase 1, open-label, fixed-sequence, drug-drug interaction study to investigate the effect of single and multiple oral doses of SB17170 on the pharmacokinetics of SB_MDZ in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB17170 + SB_MDZ | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB17170 | Drug | PO, QD |
| |
| SB_MDZ |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of SB_MDZ | Day 0, 6, 15 | |
| AUC of SB_MDZ | Day 0, 6, 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of SB_MDZ | Day 0, 6, 15 | |
| AUCinf of SB_MDZ | Day 0, 6, 15 | |
| T1/s of SB_MDZ |
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Inclusion Criteria:
Exclusion Criteria:
Individuals with a clinically significant disease or history in hepatobiliary, renal, nervous, respiratory, immune, hemato-oncology, cardiovascular, urinary system, or psychiatric disorder
Individuals with a history of a gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc) or surgeries (except for simple appendectomy or hernia surgery) that may affect the safety and pharmacokinetic assessment of the investigational product (IP)
Individuals with hypersensitivity or significant history of hypersensitivity to drugs, including ingredients of the IP (SB17170 or its metabolite SB1703, SB_MDZ, and benzodiazepine-class drugs) or other drugs (e.g., aspirin, antibiotics)
Individuals with a current or historical condition that may increase risk, as determined by the investigator or as indicated in SB_MDZ's product information
Individuals who exhibited one or more of the following results in clinical laboratory tests during the screening, including additional tests
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| Drug |
IV |
|
| Day 0, 6, 15 |
| CL of SB_MDZ | Day 0, 6, 15 |
| Vz of SB_MDZ | Day 0, 6, 15 |