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The purpose of this study is to evaluate the drug-drug interaction of SH229 tablets and Daclatasvir dihydrochloride tablets. The study also evaluates the pharmacokinetics and tolerability of co-administration of SH229 tablets and Daclatasvir dihydrochloride tablets in healthy subjects. This study provides evidence for the designing of following clinical trial protocols.
A total of 28 evaluable healthy subjects will be enrolled in this study. The dose of SH229 is 600 mg. The dose of Daclatasvir dihydrochloride is 60 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily. |
|
| Cohort B | Experimental | SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SH229 | Drug | tablet, oral, 600 mg once daily for day 1 to day 14 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Cohort A and Cohort B [Safety and tolerability] | Up to 1 month after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax, ss | Time of maximum observed concentration; safety and validity criteria | Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose |
| Cmax, ss | Maximum observed concentration; safety and validity criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, MD | Phase I Clinical Trial Unit, The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I Clinical Trial Unit, The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| C549273 | daclatasvir |
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| SH229 |
| Drug |
tablet, oral, 600 mg once daily for day 8 to day 14 |
|
| Daclatasvir dihydrochloride | Drug | tablet, oral, 60 mg once daily for day 8 to day 14 |
|
| Daclatasvir dihydrochloride | Drug | tablet, oral, 60 mg once daily for day 1 to day 14 |
|
| Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose |
| Cmin, ss | Minimum observed concentration; safety and validity criteria | Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose |
| t1/2, ss | Elimination half-life; safety and validity criteria | Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose |
| AUC0-24, ss | Area under the concentration-time curve (AUC) from time 0 to 24 hours; safety and validity criteria | Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose |
| AUC0-72, ss | Area under the concentration-time curve (AUC) from time 0 to 72 hours; safety and validity criteria | Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose |
| AUC0-∞, ss | Area under the concentration-time curve (AUC) from time 0 to infinity; safety and validity criteria | Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose |
| CL/F ss | Apparent clearance; safety and validity criteria | Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose |
| DF | Degree of fluctuation; safety and validity criteria | Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose |