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| Name | Class |
|---|---|
| AnHeart Therapeutics Inc. | INDUSTRY |
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AB-106-C111 is China-only study, for investigating the drug interaction between AB-106 and P-gp substrate (Digoxin). (n=16)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| digoxin cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB-106, digoxin | Drug | Period 1, single dose of 0.25mg digoxin; Period 2, Coadministrate AB-106 600mg and 0.25mg digoxin |
|
| Measure | Description | Time Frame |
|---|---|---|
| The PK exposure parameters of digoxin | Area under the plasma concentration versus time curve (AUC) | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| The PK parameters of digoxin | Peak Plasma Concentration (Cmax) | 17 days |
| The PK parameters of digoxin | Time to drug peak plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuangmiao Wang | AnHeart Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| 17 days |
| The PK parameters of digoxin | Percentage of area under the curve from time of the last quantifiable concentration to infinity to area under the curve to infinity (AUC_extr%) | 17 days |
| The PK parameters of digoxin | Lambda_z, first-order rate constant associated with the terminal portion of the curve (λz) | 17 days |
| The PK parameters of digoxin | Terminal phase elimination half life (t1/2) | 17 days |
| The PK parameters of digoxin | Apparent total clearance (CL/F), Vz/F | 17 days |
| The PK parameters of digoxin | Apparent volume of distribution (Vz/F) | 17 days |
| Safety assessment | Adverse events (AEs) | 35 days |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |