Invasive fungal infections
Conditions
Interventions
Group A:10 subjects received the test drug in the fasting state (200 mg, 1h), 2 subjects received 5% (glucose injection, 250 mL: 12.5 g, 1h) in the fasting state.
Group B:10 subjects received the test drug in the fasting state (400 mg, 1h), 2 subjects received 5% (glucose injection, 250 mL: 12.5 g, 1h) in the fasting state.
Group C:10 subjects received the test drug in the fasting state (600 mg, 1h), 2 subjects received 5% (glucose injection, 250 mL: 12.5 g, 1h) in the fasting state.
Group D:10 subjects received the test drug in the fasting state (600 mg, 3h), 2 subjects received 5% (glucose injection, 250 mL: 12.5 g, 3h) in the fasting state.
Sponsors
Clinical Trial Research Center of the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.18-45 years old healthy male or female (including boundary value); 2. Male weight >= 50.0 kg, female weight >= 45.0 kg, body mass index (BMI = weight (kg)/height 2 (m2)) between 19.0-28.0 kg/m2 (including the boundary value); 3. Volunteers have no plans to have children or donate sperm/eggs for at least 3 months from the signing of the informed consent form to the end of the study, and voluntarily take effective non-drug contraceptive measures (including partners) during the test period; 4. Have a detailed understanding of the nature, significance, possible benefits, possible inconvenience and potential risks of the trial before the trial, and voluntarily participate in this clinical trial, be able to communicate well with the investigators, comply with the requirements of the entire study, and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to the test drug (including excipients, echinocandin drugs), or have a history of specific allergies (asthma, urticaria, eczema, etc.), or those with allergic constitution (such as two or more drugs, food and hay fever); 2. Previously or currently have any history of diseases that may affect the safety of volunteers participating in the trial or the internal process of the research drug, including: blood system (such as hemolysis reaction), circulatory system, digestive system, urinary system, respiratory system, nervous system, Patients with clear medical history of immune system, endocrine system, mental abnormalities and metabolic disorders, or other diseases that are not suitable for participating in clinical trials; 3. Those who have undergone major surgery within 3 months (90 days) before screening; 4. Those who have undergone surgery that may significantly affect the pharmacokinetic characteristics or safety evaluation of the investigational drug, or those who plan to perform surgery during the study period; 5. Those who have received inactivated vaccine within 1 month before screening, received live/attenuated vaccine within 3 months before screening or plan to receive inactivated/live/attenuated vaccine during the trial; 6. Those who have used any medicine or health care product (including Chinese herbal medicine) within 14 days before administration; 7. Those who are known during the screening period may need to receive other drug treatment during the study period; 8. Those who have used any clinical research drugs within 3 months (90 days) before screening, or plan to participate in other clinical trials during this study; 9. Blood donation/blood loss >= 400 mL (except female physiological blood loss) within 3 months (90 days) before screening, receiving blood transfusion or using blood products, or planning to donate blood during the trial or within 1 month after the trial; 10. Those who smoked more than 5 cigarettes per day on average within 3 months (90 days) before screening, or who could not quit smoking during the test; 11. Frequent drinkers (drinking more than 14 units of alcohol per week on average, 1 unit = 360 mL beer or 45mL spirits with 40% alcohol or 150mL wine) within 3 months (90 days) before screening, or who cannot stop drinking during the test drinker; 12. Those who drank excessive tea, coffee or caffeinated beverages (more than 8 cups per day on average, 1 cup = 200 mL) within 3 months (90 days) before screening; 13. Those who eat special food (such as grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeine and other food or drink) within 48 hours before administration; 14. Those who cannot eat or have difficulty swallowing, or have special requirements for diet and cannot follow a unified diet; 15. The results of total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), prothrombin time (PT) or international normalized ratio (INR) during the screening period are not within the normal range; Or vital signs during the screening period or baseline period, other laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), physical examination, abdominal B-ultrasound, normal Chest X-ray examination results judged by the research doctor to be abnormal and clinically significant; 16. The results of 12-lead electrocardiogram are judged by the resea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Vital signs;Laboratory examination;Twelve lead electrocardiogram;Physical examination; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Research Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed