Paroxysmal nocturnal hemoglobinuria
Conditions
Interventions
Rifampicin group:On the 1st and 20th day, take a single dose of NTQ5082 capsules at an empty stomach state (fasting for at least 10 hours before administration), 200 milligrams (2 capsules × 100 milli
Clopidogrel group:On the 1st and 9th days, on an empty stomach (fasting for at least 10 hours before administration), take a single dose of NTQ5082 capsules 200 mg (2 capsules × 100 mg) in the morning
Sponsors
Clinical Trial Center of Xiangya Third Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female, aged 18 years and above and 45 years and below (inclusive of the boundary values); 2.19.0 kg/m^2 = 50 kg, and for females, the weight should be >= 45 kg; 3. Signed the informed consent form before the trial and fully understood the trial content, process, and possible adverse reactions; 4. The trial participants can communicate well with the researchers and understand and comply with all the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Those who participated in any clinical trial within the previous 3 months and took any clinical trial drugs; 2. Those who had chronic or active digestive tract diseases such as esophageal diseases, gastritis, gastric ulcers, gastroesophageal reflux, enteritis, active gastrointestinal bleeding or digestive tract surgery within the previous 3 years, and the investigator believes that it still has clinical significance at present; 3.Those with definite diseases in the central nervous system, cardiovascular system, digestive system, respiratory system, endocrine system, urinary system, blood and lymph system, or metabolic disorders and require medical intervention or other diseases that are not suitable for participating in clinical trials (such as a history of mental illness, etc.); 4. Those who had symptoms such as nausea, vomiting, or diarrhea within 14 days before the first administration, and the investigator believes that they are not suitable for participating in the trial; 5. Those with known or suspected history of immunodeficiency disease (such as a history of frequent recurrent infections), hereditary or acquired complement deficiency; 6. Those who had a clear history of capsule microbial infection within the previous 6 months; including but not limited to: Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae, Legionella pneumophila infection history, etc.; 7. Those who have a history of tuberculosis infection or are currently suffering from tuberculosis; 8. Those who had active systemic bacterial, viral or fungal infections within 14 days before the first administration; 9). Those who had active pathological bleeding in the past or before the administration, such as digestive ulcers or intracranial bleeding; 10. Those with liver dysfunction, kidney dysfunction, or biliary obstruction; 11. Those who have an allergy to the test drugs, any of their components, or related preparations, or have a history of drug, food, or other substance allergies; 12. Those who cannot tolerate venipuncture or have a history of fainting or needle shock; 13. Those who have undergone surgery judged by the investigator to affect drug absorption, distribution, metabolism, or excretion within the previous 6 months; or those who have undergone surgery within the previous 30 days; or those who plan to undergo surgery during the trial; 14. Those who have used any drugs within the previous 14 days (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, Chinese patent medicines, and dietary supplements, etc.); or those whose drugs have been within 5 half-lives of screening (with the longer time being the standard); 15.Those who have received vaccines or attenuated live vaccines (meningococcal vaccine and pneumococcal vaccine) before the screening, or plan to receive vaccines during the trial; 16. Those whose QTc is >= 450 msec (for males) or >= 460 msec (for females) at the time of screening; 17. Those who have donated blood or suffered massive blood loss (> 400 mL), received blood transfusion or used blood products within the previous 3 months, or plan to donate blood or blood components within 3 months after the trial; 18. Those who are drug abusers or have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within the previous 1 year; or those with positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic exposure parameters: Cmax, AUC0-t, AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-lead electrocardiogram indicators;Vital signs; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed