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This is a phase I study to assess the drug-drug interaction of XZP-3287 and Clarithromycin/Rifampicin. The study also evaluates the pharmacokinetic and tolerability of XZP-3287 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XZP-3287 combined with clarithromycin | Experimental | XZP-3287 combined with clarithromycin |
|
| XZP-3287 combined with rifampicin | Experimental | XZP-3287 combined with rifampicin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XZP-3287 combined with clarithromycin | Drug | Drug: XZP-3287, oral, 120 mg once daily for day 1 and day 12 Drug: clarithromycin, oral, 500 mg twice daily for day 8 to day 21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary PK Endpoints | Cmax | day 1~day 20/day22 |
| Primary PK Endpoints | AUC0-∞ | day 1~day 20/day22 |
| Primary PK Endpoints | AUC0-t | day 1~day 20/day22 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary PK measures | Tmax | day 1~day 20/day22 |
| Secondary PK measures | T1/2 | day 1~day 20/day22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimin Zhou | Contact | 0086-13647211506 | zhouzhimin@xuanzhubio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | Anhui | China |
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| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| XZP-3287 combined with rifampicin | Drug | Drug: XZP-3287, oral, 360 mg once daily for day 1 and day 14 Drug: rifampicin, oral, 600 mg once daily for day 8 to day 19 |
|
| Secondary PK measures | CL/F | day 1~day 20/day22 |
| Secondary PK measures | Vz/F | day 1~day 20/day22 |
| SAFETY/TOLERABILITY | Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0 | Up to 10 days after last dose |
| Organic Chemicals |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |