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This study is a single-center, single-sequence, self-controlled, open design, aiming to investigate the effects of rifampicin and clarithromycin on the pharmacokinetics of RSS0343 in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Rifampicin Capsules Group | Experimental |
| |
| Cohort B: Clarithromycin Tablets Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSS0343 Tablet; Rifampicin Capsules | Drug | RSS0343 Tablet; Rifampicin Capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax; The maximum plasma concentration | Day1-Day38 | |
| AUC0-t; From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration | Day1-Day38 | |
| AUC0-inf;Area under the concentration curve from time 0 to extrapolated infinite time | Day1-Day38 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax; Time to maximum plasma concentration | Day1-Day38 | |
| t1/2; Terminal half-life | Day1-Day38 | |
| CL/F; Apparent clearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruifang Guan | Contact | +86- 0518-82342973 | ruifang.guan.rg1@hengrui.com | |
| Hongda Lin | Contact | +86- 0518-82342973 | hongda.lin@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong | 510405 | China |
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| RSS0343 Tablet; Clarithromycin Tablets | Drug | RSS0343 Tablet; Clarithromycin Tablets |
|
| Day1-Day38 |
| Vz/F; Apparent volume of distribution | Day1-Day38 |
| Safety ;Incidence and severity of adverse events | Day1-Day45 |
| ID | Term |
|---|---|
| D012293 | Rifampin |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| 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 |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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