None
Conditions
Interventions
itraconazole:itraconazole and midazolam
rifampicin: rifampicin and midazolam
Sponsors
Beijing Friendship Hospital,Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Those who voluntarily sign the informed consent before the activities related to this trial, understand the procedures and methods of this trial, and are willing to complete this trial in strict accordance with the clinical trial plan; 2. Male healthy subjects aged 18-45 (including both values, subject to the signing of informed consent); 3. The weight shall not be less than 50kg. Body mass index (BMI): 19-26kg / m2 (including both ends) (BMI = weight (kg) / height 2 (M2)); 4. Qualified subjects with fertility agree to use reliable contraceptive methods (barrier method or abstinence) from the signing of informed consent to 6 months after the end of the last medication, and the subjects do not donate sperm within the above specified time. Unless permanent contraceptive measures have been taken, such as vasectomy; 5. Be able to communicate well with researchers, understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution, or a history of allergy to any research drug or other similar structural drugs; 2. Those who have or are currently suffering from serious diseases of cardiovascular, respiratory, digestive, endocrine, hematopoietic, mental / neurological systems; 3. Known to suffer from sleep apnea syndrome, upper respiratory tract obstruction, asthma, chronic obstructive pulmonary disease (COPD) and other respiratory diseases; 4. Those who have previously undergone surgery that may affect drug absorption, distribution, metabolism and excretion (such as subtotal gastrectomy) or who are expected to have surgery or hospitalization plans during the trial; 5. Those who have used CYP3A4 strong inducer and strong inhibitor within 2 weeks before screening; 6. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicine or health products within 2 weeks before screening; 7. Those who have a history of drug abuse within one year before screening or have a positive urine drug screening test; 8. Those who smoke more than 5 cigarettes a day on average within 6 months before screening; 9. Drinking more than 14 units of alcohol per week within 4 weeks before screening (1 unit = 285ml beer; 25ml spirits; 150ml wine), or positive alcohol breath test; 10. Those who have ingested grapefruit juice / grapefruit juice, foods or beverages rich in methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours before administration, or have strenuous exercise and other factors affecting drug absorption, distribution, metabolism, excretion and so on; 11. Those who have participated in the clinical trial of any drug or medical device within 3 months before screening (subject to the Administration); 12. Those who lose blood or donate more than 200 ml blood within 4 weeks before screening, or those who plan to donate blood during the study or within 1 month after the end of the study; 13. Those with abnormal and clinical significance after comprehensive physical examination (vital signs, physical examination), routine laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), x-chest film (positive position) or CT; 14. Abnormal 12 lead ECG with clinical significance (such as tachycardia / bradycardia requiring drug treatment, degree II-III atrioventricular block, average value of QT interval (QTCF) corrected by fridericia formula in ECG > 450ms, or other clinically significant abnormalities determined by clinicians); 15. hepatitis B surface antigen positive or previous history of hepatitis B; Hepatitis C antibody positive; 16. Human immunodeficiency virus antibody positive or Treponema pallidum antibody positive; 17. Those who have been vaccinated within 4 weeks before screening or plan to be vaccinated during the trial; 18. The researcher believes that there are any circumstances that may cause the subject to fail to complete the study or bring obvious risks to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
China
Contacts
Public ContactRuihua Dong
Beijing Friendship Hospital,Capital Medical University
Outcome results
None listed