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| Name | Class |
|---|---|
| Hunan Provincial People's Hospital | OTHER |
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This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | ASC41 one tablet, on Day 1 before mealï¼›ASC41 one tablet, on Day 15 after meal. |
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| Group 2 | Experimental | ASC41 one tablet, on Day 1 after mealï¼›ASC41 one tablet, on Day 15 before meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC41 tablet | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC of ASC41 | Evaluate the Area under the plasma concentration versus time curve after single oral dose of ASC41 administered to healthy volunteers. | Up to 19 days |
| Cmax of ASC41 | Evaluate the Peak Plasma Concentration after single oral dose of ASC41 administered to healthy volunteers. | Up to 19 days |
| Measure | Description | Time Frame |
|---|---|---|
| t1/2 of ASC41 | Evaluate the Terminal-Phase Half-Life after single oral dose of ASC41 administered to healthy volunteers. | Up to 19 days |
| CL/F of ASC41 | Evaluate the Apparent Systemic Clearance after single oral dose of ASC41 administered to healthy volunteers. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan provincial people's hospital | Changsha | Hunan | China |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050171 | Dyslipidemias |
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| Up to 19 days |
| Vd/F of ASC41 | Evaluate the Apparent Volume of Distribution after single oral dose of ASC41 administered to healthy volunteers. | Up to 19 days |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 19 days | Up to 19 days |
| D052439 |
| Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |