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This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMKX001899+Itraconazole | Experimental | Enrolled subjects were treated with JMKX001899 on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 4 to Day 6. JMKX001899 and itraconazole were administered simultaneously after a standardized meal on Day 7. On Day 8 to Day 9, itraconazole was orally administered once after a standard meal |
|
| JMKX001899+Rifampin | Experimental | Enrolled subjects were treated with JMKX001899 after high fat meal on Day 1 and an empty stomach on Day 4. Rifampin was administered orally once daily on an empty stomac from Day 7 to Day 15, Day 17and Day 18. JMKX001899 and Rigampin were administered simultaneously on an empty stomach on Day 16. |
|
| JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) | Experimental | Enrolled subjects were treated with Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) on an empty stomach on Day 1. JMKX001899 was administered orally once daily after a standardized meal from Day 9 to Day 20 and Day 22. Cocktail and JMKX001899 were administered simultaneously on an empty stomach on Day 8 and Day 21. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX001899 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximum concentrations (Cmax ) for plasma | approximately 3 days after first dose | |
| area under the curve from time 0 to infinity(AUC0-inf) for plasma | approximately 3 days after first dose | |
| area under the curve from time 0 to the last time point (AUC0-t) for plasma | approximately 3 days after first dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JING XU | Contact | +86-021-52887926 | xujing2@jemincare.com |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D008874 | Midazolam |
| D012293 | Rifampin |
| D003915 | Dextromethorphan |
| D000068718 | Rosuvastatin Calcium |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Oral |
|
| Midazolam | Drug | Oral |
|
| Rifampin | Drug | Oral |
|
| dextromethorphan | Drug | Oral |
|
| Rosuvastatin | Drug | Oral |
|
| digoxin | Drug | Oral |
|
| D010879 |
| Piperazines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |