Insomnia characterized by difficulty falling/maintaining sleep
Conditions
Interventions
Rifampicin group:Rifampicin
Itraconazole group:Itraconazole
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: To be selected, all the following criteria are met: 1) Chinese healthy subjects, male or female. 2) Age: 18 ~ 50 years old (including the threshold). 3) Body weight: male >= 50.0kg, female >= 45.0kg, BMI: 18.0 ~ 28.0kg /m2 (including the boundary value). 4) Understand and sign the informed consent and volunteer to participate in the study.
Exclusion criteria
Exclusion criteria: One of the following conditions, not selected: 1) People who are allergic to test drugs (including YZJ-1139, rifampicin, itraconazole) or their components, or have a history of allergy or allergic reaction to other drugs, food; 2) Patients with dysphagia; 3) Patients with a history of needle and blood sickness, difficulty in venipuncture or intolerance to venipuncture; 4) Those who have special requirements on diet and cannot abide by the uniform diet; 5) A history of heart, liver, lung, kidney, digestive tract, blood system, and neuropsychiatric system diseases, including anxiety, depression, etc., which were judged to be clinically significant by the researchers; 6) had surgery within 3 months before or during the screening period, or had surgery affecting drug absorption, distribution, metabolism, or excretion, or planned to have surgery during the study period; 7) Abnormal vital signs, physical examination, laboratory examination, 12-lead electrocardiogram and other abnormalities of clinical significance; 8) Any drugs used to inhibit or induce the activity of liver drug enzyme CYP3A4 within 28 days before screening (such as inducers -- barbiturates, carbamazepine, rifampicin, phenytoin, glucocorticoids, St. John's wort, etc.; Inhibitors -- SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 9) People who have taken any medicines and herbal medicines, over-the-counter medicines or food supplements such as vitamin and calcium within 14 days before the first administration; 10) Those who had been vaccinated within 14 days before screening; 11) Serological tests (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), Treponema pallidum specific antibody (ANTITP) have one or more positive results; 12) Regular drinkers within the previous 3 months were screened, i.e., those who drank more than 14 units of alcohol per week (1 unit =360mL beer or 45mL 40% spirit or 150mL wine) or could not stop using any alcohol products during the study period, or those whose breath breath test results were greater than 0.0mg/100mL; 13) Those who smoked more than 5 cigarettes per day in the previous 3 months, or could not stop using any tobacco products during the trial, or were screened positive for nicotine; 14) Have a history of drug abuse, or have one or more positive results of urine drug screening (morphine, tetrahydrocannabinolic acid, methamphetamine, dimethyldimethamphetamine, ketamine) in screening phase; 15) Frequent use of hypnotic drugs (> once a month), or positive results of benzodiazepine urine drug screening in screening stage; 16) Screening participants who had participated in any drug clinical trials within the previous 3 months; 17) Those who donated blood or had a large amount of blood loss >= 400mL, received blood transfusion or used blood products within the previous 3 months, and those who planned to donate blood during the trial were screened; 18) Have eaten grapefruit, grapefruit, lime, carambola and other fruits that affect metabolism or food or beverage prepared from them when checked in at D-1; Have eaten chocolate, caffeinated or xanthine rich food or drink (coffee, strong tea, cola, etc.); 19) Those who consumed excessive amounts of tea, coffee or caffeine-rich beverages (more than 8 cups, 1 cup =250 mL) every day in the previous 3 months were screened; 20) The pregnancy test resul
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t?AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, t1/2z, ?z, Vz/F, CLz/F, MRT0-t, MRT0-8, AUC_%Extrap, M/P;Vital signs, physical examination, safety laboratory examination, and 12-lead electrocardiogram; | — |
Countries
China
Contacts
Public ContactHengyan Qu
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed