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This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI351+ itraconazole | Other | Enrolled subjects were treated with IBI351 on an empty stomach on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 3 to Day 6. IBI351 and itraconazole were administered simultaneously on an empty stomach on Day 7. On Day 8, itraconazole was orally administered once after a standard meal. |
|
| IBI351+ dextromethorphan | Other | Enrolled subjects were orally administered dextromethorphan on an empty stomach on Day 1. IBI351 and dextromethorphan were orally administered simultaneously on an empty stomach on Day 3, followed by IBI351 12 hours later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | Itraconazole was administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| maximum concentrations (Cmax ) for IBI351 | approximately 10 days | |
| maximum concentrations (Cmax ) for dextromethorphan | approximately 10 days | |
| area under the curve from time 0 to infinity(AUC0-inf) for IBI351 | approximately 10 days | |
| area under the curve from time 0 to infinity(AUC0-inf) for dextromethorphan | approximately 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| time-to-maximum concentration (Tmax) for IBI351 | approximately 10 days | |
| half-life (t1/2) for IBI351 | approximately 10 days | |
| area under the curve from time 0 to time (AUC0-t) for IBI351 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Suzhou University | Suzhou | Jiangsu | China |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D003915 | Dextromethorphan |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| IBI351 |
| Drug |
IBI351 was administered orally |
|
| Dextromethorphan | Drug | Dextromethorphan was administered orally |
|
| approximately 10 days |
| apparent clearance (CL/F) for IBI351 | approximately 10 days |
| apparent volume of distribution(Vz/F) for IBI351 | approximately 10 days |
| time-to-maximum concentration (Tmax) for dextromethorphan | approximately 10 days |
| half-life (t1/2) for dextromethorphan | approximately 10 days |
| area under the curve from time 0 to time (AUC0-t) for dextromethorphan | approximately 10 days |
| apparent clearance (CL/F) for dextromethorphan | approximately 10 days |
| apparent volume of distribution(Vz/F) for dextromethorphan | approximately 10 days |
| area under the curve for dextrorphan | approximately 10 days |
| maximum concentrations (Cmax ) for dextrorphan | approximately 10 days |
| number of participants with abnormal hematology tests | approximately 10 days |
| number of participants with abnormal chemistry parameters | approximately 10 days |
| number of participants with abnormal vital signs | approximately 10 days |
| number of participants with abnormal physical examination findings | approximately 10 days |
| number of participants with abnormal ECG readings | approximately 10 days |
| D010879 |
| Piperazines |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |