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The study is a randomized , open-label, two-stage crossover food effect study of single doses of DDO-3055 tablets in healthy subjects. 14 healthy subjects were randomly divided into groups A and B, 7 subjects in each group. Two stage washout period is 6 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental |
| |
| group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDO-3055 tablet | Drug | DDO-3055 tablet, 2 single doses separated by 6 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) of DDO-3055 | up to 2 days | |
| Maximum plasma concentration (Cmax) of DDO-3055 | up to 2 days | |
| Time to maximum observed serum concentration (Tmax) of DDO-3055 | up to 2 days | |
| Terminal elimination half-life (T1/2) of DDO-3055 | up to 2 days | |
| Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055 | up to 2 days | |
| Apparent volume of distribution after oral administration (V/F) of DDO-3055 | up to 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of endogenous erythropoietin from baseline | up to 2 days | |
| Safety and tolerability | Use the incidence and severity of adverse events to assess safety and tolerability | up to 9 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100037 | China |
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