Anemia in Chronic Kidney Disease
Conditions
Brief summary
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.
Interventions
DRUGDDO-3055 tablet
DDO-3055 tablet, 2 single doses separated by 6 days.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Healthy male volunteers, aged 18\ 45. * 2\. Body weight ≥ 50 kg, body mass index (BMI) between 18 to 28. * 3\. Hemoglobin is in the normal range. * 4\. Signed informed consent.
Exclusion criteria
* 1\. Vital signs, physical examination, laboratory results are abnormal and clinically significant. * 2\. Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases. * 3\. Suspected allergy to the active ingredient or excipient of the experimental drug. * 4\. Have used erythropoietin within 1 month prior to screening or are currently using erythropoietin. * 5\. Had donated blood or blood transfusion within 3 months prior to screening. * 6\. Vein blood collection is difficult or physical condition can not afford blood collection. * 7\. Hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCVAb), Syphilis antibody, human immunodeficiency virus antibody (HIVAb)were positive. * 8\. Average daily smoking ≥5 cigarettes within 3 months before screening; average daily intake of alcohol within one week is more than 15g (15g alcohol is equivalent to 450mL beer or 150mL wine or 50mL low-alcohol liquor);or 2 days before taking the study drug and during the trial take the tobacco and alcohol and caffeinated foods or drinks, and have special dietary requirements and cannot follow a uniform diet. * 9\. 3 months prior to screening involved in any drug or medical device clinical trials, or within 5 half-life of drugs before screening. * 10\. Any health care products, Over-the-counter drugs or prescription drugs that affects the absorption, distribution, metabolism and excretion of the experimental drug was used within 1 month before the administration. * 11\. With a history of drug abuse or screening visit/baseline visit urine drug abuse screening positive. * 12\. Subjects who are unwilling to take contraceptives or who are likely to donate sperm during the trial and within 30 days after administration; or who do not agree to physical contraception during the trial. * 13\. Other conditions in which the study physician considered the subject not suitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Terminal elimination half-life (T1/2) 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 |
| 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 |
| Area under the concentration-time curve (AUC) of DDO-3055 | up to 2 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | up to 9 days | Use the incidence and severity of adverse events to assess safety and tolerability |
| Change of endogenous erythropoietin from baseline | up to 2 days | — |
Countries
China
Outcome results
None listed