Obesity
Conditions
Interventions
Group 1:Sixteen males are planned to be enrolled. Subjects took 2mg midazolam orally on an empty stomach in D1 to detect midazolam concentration
Group 2:Sixteen males are planned to be enrolled. Subjects took febuxostat 80mg orally on an empty stomach D1 to detect febuxostat concentration
Group 3:A total of 100 healthy subjects were included in the phase 1 clinical trial. 5 ml of venous blood was collected for the detection of drug metabolism enzyme related gene polymorphism, gene expr
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Those who are willing to sign informed consent before the activities related to the study, understand the procedures and methods of the study, and are willing to complete the study in strict compliance with the clinical trial protocol; 2. Male subjects aged between 18 and 50 years (inclusive, subject to signing informed consent); 3. Body mass index (BMI) : 28-40kg/m2 (both ends included) (BMI= weight (kg)/height 2 (m2)); 4. Eligible fertile subjects agree to use a reliable method of contraception (barrier method or abstinence) from signing the informed consent until 6 months after the end of the last medication, and to refrain from sperm donation during the specified period. Unless permanent contraceptive measures have been taken, such as vasectomy; 5. Be able to communicate well with researchers and understand and abide by the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution, or a history of allergy to any study drug or other drug of similar structure; 2. Patients with past or present serious diseases of cardiovascular, respiratory, digestive, endocrine, hematopoietic, mental/nervous systems; 3. Known patients with sleep apnea syndrome, upper respiratory tract obstruction, asthma, chronic obstructive pulmonary disease (COPD) and other respiratory diseases; 4. Patients who have previously undergone surgery (e.g., subtotal gastrectomy) that may affect drug absorption, distribution, metabolism or excretion, or who are expected to have surgery or hospitalization during the study period; 5. Patients who had used CYP3A4, CYP2C8, P-GP strong inducer or suppressor within 2 weeks before screening (see Appendix 2 for details); 6. Those who have used any prescription drugs, nonprescription drugs, Chinese herbal medicine or health care products within 2 weeks prior to screening; 7. Patients with a history of drug abuse or positive urine drug screening test within 1 year prior to screening; 8. Those who smoked more than 5 cigarettes per day in the previous 6 months were screened; 9. Drinking more than 14 units of alcohol per week in the 4 weeks prior to screening (1 unit = beer 285mL; Liquor 25 ml; Wine 150mL), or alcohol breath test positive; 10. Had consumed grapefruit juice/grapefruit juice, food or drink rich in methyl xanthine (such as coffee, tea, cola, chocolate, energy drink), strenuous exercise or other factors affecting drug absorption, distribution, metabolism and excretion within 48 hours before administration; 11. Patients who lost blood or donated more than 200 mL blood within 4 weeks prior to screening, or who planned to donate blood during the study period or within 1 month after the study; 12. Abnormal 12-lead ecg examination is clinically significant (such as tachycardia/bradycardia requiring drug treatment, II-III atrioventricular block, average QT interval (QTcF) corrected by Fridericia formula > 450ms or other clinically significant abnormalities determined by clinicians); 13. Hepatitis B surface antigen positive or previous history of hepatitis B; Hepatitis C antibody positive; 14. Positive antibodies to human immunodeficiency virus or treponema pallidum; 15. The Investigator considers that there are any conditions that may cause the subject to fail to complete the study or present a significant risk to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Drug metabolism enzyme activity;Drug metabolism enzyme metabonomics;Enzyme genomics of drug metabolism; | — |
Countries
China
Contacts
Public ContactRuihua Dong
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed