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This is a phase I study to assess the drug-drug interaction of SH-1028 tablets and Itraconazole/Rifampicin tablets. The study also evaluates the pharmacokinetic and tolerability of SH-1028 tablets in healthy subjects. This study provides evidence for the designing of following clinical trial protocols.
A total of 40 evaluable healthy male subjects will be enrolled in this study.The subjects will be divided into two groups, A and B, with 20 people in each group.
In the itraconazole study (Group A), patients received single-dose SH-1028 200 mg on Days 1 and 12 and itraconazole(200 mg twice daily) on Days 8-14 orally.
In the rifampicin study (Group B), patients received SH-1028 200mg once daily on Days 1 and 14 and rifampicin 600 mg once daily on Days 8-16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole and SH-1028 | Experimental | In the itraconazole study, patients received single-dose SH-1028 200 mg on Days 1 and 12 and itraconazole(200 mg twice daily) on Days 8-14 orally. |
|
| Rifampicin and SH-1028 | Experimental | In the rifampicin study, patients received SH-1028 200mg once daily on Days 1 and 14 and rifampicin 600 mg once daily on Days 8-16 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SH-1028 | Drug | tablet, oral, 200 mg once daily for day 1 and day 12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetics of SH-1028 by assessment of maximum plasma concentration | Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose |
| AUC(0-last) | Pharmacokinetics of SH-1028 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint | Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose |
| AUC(0-∞) | Pharmacokinetics of SH-1028 by assessment of area under the concentration time curve from time 0 to infinity | Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Safety and tolerability | Up to 10 days after last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huan Zhou, Ph D | Contact | 13665527160 | zhouhuan@bbmc.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital with Bengbu Medical College | Bengbu | Anhui | 233004 | China |
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| ID | Term |
|---|---|
| C000728623 | SH-1028 |
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | capsule, oral, 200 mg twice daily for day 8 to day 14 |
|
| Rifampicin | Drug | capsule, oral, 600 mg once daily for day 8 to day 16 |
|
| 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 |