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This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design.
Part II is the drug-drug interaction study, an open-label and sequential design. 32 healthy subjects are planned to be enrolled and divided into group A and group B. Group A is to evaluate the influence of itraconazole as CYP3A4 strong inhibitory on HLX208. Group B was to evaluate the effect of rifampicin as a strong inducer of CYP3A4 on HLX208.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX208 in the fast state | Experimental | HLX208 900mg in the fast state |
|
| HLX208 in the fed state | Experimental | HLX208 900mg in the fed state |
|
| HLX208 + Itraconazole group | Experimental | HLX208 + Itraconazole group |
|
| HLX208 + rifampicin group | Experimental | HLX208 + rifampicin group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX208 | Drug | Subjects will receive treatment HLX208 900 mg in the fast state followed by 7 days washout ,then receive treatment HLX208 900 mg in the fed state |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter Cmax of HLX208 | Cmax of HLX208 | up to 48 hours |
| Pharmacokinetics parameter AUC0-t of HLX208 | AUC0-t of HLX208 | up to 48 hours |
| Pharmacokinetics parameter AUC0-inf of HLX208 | AUC0-inf of HLX208 | up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| other pharmacokinetics parameter Tmax of HLX208 | Tmax of HLX208 | up to 48 hours |
| other pharmacokinetics parameter Tlag of HLX208 | Tlag of HLX208 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| HLX208 | Drug | Subjects will receive treatment HLX208 900 mg in the fed state followed by 7 days washout ,then receive treatment HLX208 900 mg in the fast state. |
|
| HLX208 | Drug | 450 mg |
|
| HLX208 | Drug | 900 mg |
|
| Itraconazole 200 mg | Drug | 200 mg |
|
| Rifampicin | Drug | 600mg |
|
| up to 48 hours |
| other pharmacokinetics parameter t1/2 of HLX208 | t1/2 of HLX208 | up to 48 hours |
| other pharmacokinetics parameter CL/F of HLX208 | CL/F of HLX208 | up to 48 hours |
| other pharmacokinetics parameter Vd/F of HLX208 | Vd/F of HLX208 | up to 48 hours |
| other pharmacokinetics parameter MRT of HLX208 | MRT of HLX208 | up to 48 hours |
| other pharmacokinetics parameter %AUCex of HLX208 | %AUCex of HLX208 | up to 48 hours |
| The incidence and severity of adverse events/serious adverse events | Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) | up to 17 days after the last dose |
| D010879 |
| Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |