| Trial ID: | L0773 |
| Source ID: | NCT04197778
|
| Associated Drug: |
Ddo-3055 Tablet
|
| Title: |
Food Effect Study of DDO-3055 Tablets in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia in Chronic Kidney Disease
|
| Interventions: |
DRUG: DDO-3055 tablet
|
| Outcome Measures: |
Primary: 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 | Secondary: 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
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
14
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2020-01-06
|
| Completion Date: |
2020-01-18
|
| Results First Posted: |
|
| Last Update Posted: |
2022-06-08
|
| Locations: |
Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, 100037, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04197778
|
