Renal anemia
Conditions
Interventions
25mg group:25mg dolustat tablets
50mg group:50mg dolustat tablets
100mg group:100mg dolustat tablets
200mg group:200mg dolustat tablets
Sponsors
Yiyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.The subject must give informed consent to the test before the test, fully understand the content, process, and possible adverse reactions of the trial and voluntarily sign a written informed consent form before the trial; 2.The subject has good communication with the investigator and is able to complete the trial according to the protocol; 3.The subject has no family planning (including egg donation plan, sperm donation plan) and voluntary use of effective contraception (non-drug during the trial) within 6 months of his/her signing of informed consent; 4.Gender: Male and female; 5.Aged 18 to 45 years (including 18 and 45 years of age); 6.Body weight: Males weighing >= 50 kg and females weighing >= 45 kg, and body mass index (BMI = body weight (kg)/height^2 (m^2)) within 19.0 to 26.0 kg/m^2 (including boundary values).
Exclusion criteria
Exclusion criteria: 1.Allergies (allergies to two or more substances), or known allergies to components of the trial drug, hypoxia-inducible factor-prolyl hydroxylase inhibitors; 2.The following clinically significant diseases, including, but not limited to, respiratory, circulatory, digestive, hematologic, endocrine, immune, dermatologic, neuropsychiatric, and ophthalmology and otorhinolaryngology and other related diseases; 3.Any condition that increases the risk of bleeding, such as acute gastritis or active ulcer with bleeding, clinically significant thrombocytopenia or anemia, and active pathological bleeding or history of intracranial bleeding; 4.Patients with a history of severe gastrointestinal disease within 6 months prior to screening; 5.Patients with a history of renal insufficiency (serum creatinine greater than 1.5 times the upper limit of normal (UNL)); 6.Active liver disease and/or liver transaminases greater than 1.5 x UNL; 7.Vital signs (systolic blood pressure 90-140 mmHg, diastolic blood pressure 60-90 mmHg, body temperature 35.9-37.3 ?), physical examination, electrocardiogram, and laboratory test results are clinically meaningful if they are abnormal according to the judgment of the study doctor. 8.Positive urine drug screen; 9.Major surgery within 6 months prior to the first dose, or surgery planned during the study; 10.History of drug abuse, or use of a drug within 3 months prior to the first dose, or habitual use of any drug, including herbal remedies; 11.Smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to screening, or who did not agree to refrain from the use of any tobacco product 24 hours prior to dosing and during hospitalization; 12.History of alcoholism or regular alcohol use within 6 months of the trial, i.e., alcohol consumption of more than 14 units of alcohol per week (1 unit = 360 mL of 5% alcohol in beer or 45 mL of alcohol in 40% of spirits or 150 mL of wine in 12% of alcohol), or disagreement to discontinue alcohol intake 24 hours before dosing and during hospitalization; 13.Blood loss or donation of more than 200 mL of blood within 3 months prior to screening (except for physiological bleeding in women), or 2 treatment doses of platelets (1 treatment dose = 12U platelets) within 1 month; 14.Use of any drug within 14 days prior to screening, or use of any drug that inhibits or induces liver drug enzymes within 30 days prior to the first dose (e.g., inducers - barbiturates, entecavir, phenytoin, corticosteroids; Inhibitors - SSRI antidepressants, cimetidine, omeprazole, diltiazem, verapamil, macrolides, nitroimidazoles, sedative hypnotics, fluoroquinolones, antihistamines); 15.Overdose with tea, coffee, or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day, or disagree to refrain from drinking tea, coffee, and/or caffeinated beverages 24 hours prior to dosing and during hospitalization; 16.Disagree to avoid consumption of grapefruit and/or grapefruit juice products and/or poppy-containing products from the day of screening until the end of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics;Safety evaluation;Tolerance evaluation; | — |
Countries
China
Contacts
Public ContactLi Wei
Yiyang Central Hospital
Outcome results
None listed