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The drug-drug interaction study had been designed to investigate the effect of ZSP1273 on the pharmacokinetics of digoxin, Rosuvastatin and the effect of Itraconazole and Probenecid on the pharmacokinetics of ZSP1273
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below: Period 1: 1 × 0.25-mg digoxin tablet, 1 × 10-mg rosuvastatin tablet Period 2: 8 × 600-mg ZSP1273 tablet+1 × 0.25 mg digoxin tablet, 1 × 10-mg rosuvastatin tablet |
|
| Experimental 2 | Experimental | All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below: Period 1: 600-mg ZSP1273 tablet Period 2: 5× 500mg Probenecid tablet BID+600-mg ZSP1273 tablet Period3: (Day1)200mg Itraconazole Capsule BID,(Day2-7)200mg Itraconazole Capsule QD+600-mg ZSP1273 tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug | oral |
| |
| Rosuvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic - Cmax | Maximum observed plasma concentration | 0-168 hours |
| Pharmacokinetic -Area under the curve(AUC) | Area under the curve | 0-168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | The safety and tolerability of ZSP1273 alone and in combination with Itraconazole, rosuvastatin, Probenecid and digoxin will be examined. | Day1 to Day30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou University of Chinese medicine | Guangzhou | China |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| D000068718 | Rosuvastatin Calcium |
| C000721066 | ZSP1273 |
| D017964 | Itraconazole |
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Drug |
oral |
|
| ZSP1273 | Drug | oral |
|
| Itraconazole | Drug | oral |
|
| Probenecid | Drug | oral |
|
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D010879 | Piperazines |