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This is a phase I study to evaluate drug-drug interactions (DDIs) of JAB-21822 as a perpetrator combined with midazolam , rosuvastatin, and digoxin and to evaluate DDIs of JAB-21822 as a victim combined with itraconazole, rifampicin, and omeprazole in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAB-21822+Itraconazole | Experimental |
| |
| JAB-21822+ Rifampicin | Experimental |
| |
| JAB-21822+ Omeprazole | Experimental |
| |
| Dazolam , Rosuvastatin calcium and digoxin with JAB-21822 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-21822 | Drug | JAB-21822 was administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observed maximum concentrations (Cmax )of JAB-21822 | approximately 10 days | |
| Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822 | approximately 10 days | |
| Area under the concentration versus time curve from dose to infinity (AUC0-∞) of JAB-21822 | approximately 10 days | |
| Observed maximum concentrations (Cmax )of midazolam, rosuvastatin, and digoxin | approximately 10 days | |
| Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of midazolam, rosuvastatin, and digoxin | approximately 10 days | |
| Area under the concentration versus time curve from dose to infinity (AUC0-∞) of midazolam, rosuvastatin, and digoxin | approximately 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| He Qing B.Pharm | Beijing Gaobo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Hospital | Beijing | Beijing Municipality | 102206 | China |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D009853 | Omeprazole |
| D008874 | Midazolam |
| D000068718 | Rosuvastatin Calcium |
| D004077 | Digoxin |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Itraconazole was administered orally |
|
| Omeprazole | Drug | Omeprazole was administered orally |
|
| Midazolam , Rosuvastatin calcium and digoxin | Drug | Midazolam , Rosuvastatin calcium and digoxin was administered orally |
|
| Rifampicin | Drug | Rifampicin was administered orally |
|
| D010879 |
| Piperazines |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D011743 | Pyrimidines |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |