Renal anemia
Conditions
Interventions
T-R:Cycle 1: Test (T), Cycle 2: Reference (R, OxemiaTM)
R-T:Cycle 1: Reference (R, OxemiaTM), Cycle 2: Test (T)
Sponsors
Wuhan Infectious Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to be subjects and sign the informed consent before research begins; 2. Aged 18-45 years old (including 18 and 45), male and female (the ratio should be appropriate); 3. Male weight >= 50.0 kg, female weight >= 45.0 kg, body mass index (BMI) ranged 19.0 to 27.0 kg/m2 (including the critical value); 4. Vital signs examination during the screening period [Vital sign reference value range: systolic blood pressure 90~140mmHg, diastolic blood pressure 60~90mmHg, pulse 50~100 beats/min, body temperature (ear temperature) 35.8~37.2? (including critical value)], physical examination, electrocardiogram, chest X-ray (frontal position), clinical laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, hepatitis B/hepatitis C/AIDS/syphilis diagnosis, female pregnancy test), alcohol and urine drugs screening showed normal or the abnormality was judged by the investigator to have no clinical significance [Note: Serum creatinine < 1.5 times the upper limit of normal, liver transaminase AST, ALT < 1.5 times the upper limit of normal]; 5. Subjects should be able to communicate with investigators well, also understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. (Inquiry) Allergies to Desitustat and the components (microcrystalline cellulose, lactose, croscarmellose sodium, hypromellose, talc and magnesium stearate), allergies to hypoxia-inducible factor-prolyl hydroxylase inhibitors, allergies to two or more substances or food; 2. (Inquiry) History of chronic or serious diseases such as cardiovascular system, digestive system, genitourinary system, respiratory system, blood system, endocrine system, immune system, mental nervous system, skeletal system, etc.; 3. (Inquiry) History of disease or surgery that affects drug absorption, distribution, metabolism and excretion, such as gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, etc. within 6 months; 4. (Inquiry) Patients with any disease that increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, and patients with active pathological bleeding or a history of intracranial hemorrhage; 5. (Inquiry) Lactose intolerance (those who have experienced milk-drinking diarrhea); 6. (Inquiry) Those who have used any medicines or health products within 2 weeks before screening, have been vaccinated or have a vaccine plan during the trial; 7. (Inquiry) Those who have used any drugs that inhibit or induce liver enzymes within 30 days before the first dose (such as: inducers - barbiturates, entecavir, phenytoin, glucocorticoids; inhibitors - SSRIs); 8. (Inquiry) Those who have used oral contraceptives within 30 days before screening; those who have used long-acting estrogen or progesterone injections or implants within 6 months before screening; 9. (Inquiry) Subjects with a history of drug abuse within 6 months prior to screening; 10. (Inquiry) Users of toxins within 3 months prior to screening; 11. (Inquiry) Those who smoke more than 5 cigarettes per day within 3 months before screening, or cannot stop using any tobacco during the trial; 12. (Inquiry) The weekly alcohol consumption in the 3 months prior to screening was greater than 14 units (1 unit = 17.7 mL of ethanol, i.e. 1 unit = 357 mL of beer with an alcohol content of 5% or 43 mL of beer with an alcohol content of 40% liquor or 147 mL of wine with an alcohol content of 12%), or those who cannot abstain from alcohol during the trial; 13. (Inquiry) Excessive daily consumption of tea, coffee and/or caffeinated beverages within 3 months prior to screening (more than 8 cups, 1 cup = 250mL); or those who cannot stop drinking tea, coffee and/or caffeinated beverages during the trial; 14. (Inquiry) Those who have taken special diets (including chocolate) within 1 week before screening , foods rich in xanthine, dragon fruit, mango, grapefruit and other fruits and beverages); or those who cannot stop eating grapefruit and/or grapefruit juice products and/or products containing poppy during the test period; 15. (Inquiry) Participated in other drug clinical trials within 3 months before screening; 16. (Inquiry) Those who have a history of blood donation or heavy bleeding (>400mL) within 3 months before screening (except for female physiological blood loss) , or those who received blood transfusion or used blood products within 1 month, or those who planned to donate blood during the trial; 17. (Inquiry) Those who cannot tolerate venipuncture, those who have a history of fainting and haemorrhage; 18. (Inquiry) Those who have special requirements to diet and cannot accept a unified diet; 19. (Inquiry) From 2 we
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic;Safety evaluation; | — |
Countries
China
Contacts
Public ContactHuang Chaolin
Outcome results
None listed