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This study is a single-center, open label, self-controlled phase I clinical study, to evaluate the effects of clarithromycin or cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets in healthy Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets | Experimental |
| |
| The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindeudesivir hydrobromide tablets and Clarithromycin tablets | Drug | Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and clarithromycin tablets are administered twice from D1 to D10. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t of 116-N1 | Area under the curve from time zero to the time of the t(AUC0-t ) of 116-N1 | At pre-defined intervals up to 14 days |
| Maximum Plasma Concentration (Cmax) of 116-N1 | Maximum Plasma Concentration (Cmax) of 116-N1 | At pre-defined intervals up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Half-life(T1/2) of 116-N1 | Half-life(T1/2) of 116-N1 | At pre-defined intervals up to 14 days |
| Clearance(CL) of 116-N1 | Clearance(CL) of 116-N1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuang Li | The Sixth People's Hospital of Zhengzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhengzhou Sixth People's Hospital | Zhengzhou | Henan | 450000 | China |
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| Mindeudesivir hydrobromide tablets and Cyclosporine softgels | Drug | Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and cyclosporine sofgels are administered once at D4. |
|
| At pre-defined intervals up to 14 days |
| Tmax of 116-N1 | Peak time of 116-N1 | At pre-defined intervals up to 14 days |
| Vz/F of 116-N1 | Apparent volume of distribution of 116-N1 | At pre-defined intervals up to 14 days |
| Incidence and severity of adverse events including serious adverse events | Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations. | Up to 18 days |
| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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