None listed
Conditions
Interventions
Post meal test: T-R group:Take 1mg of the test formulation orally 30 minutes after meals, cross administer 10 days later, and take 1mg of the reference formulation orally 30 minutes after meals.
Post meal test: R-T group:Take 1mg of the reference preparation orally 30 minutes after meals, cross administer 10 days later, and take 1mg of the test preparation orally 30 minutes after meals.
Fasting test: T-R group:Oral administration of 1mg of the test formulation on an empty stomach, cross administration after 10 days, and oral administration of 1mg of the reference formulation on an em
Fasting test: R-T group:Take 1mg of the reference preparation orally on an empty stomach, cross administer after 10 days, and take 1mg of the test preparation orally on an empty stomach.
Sponsors
Affiliated Hospital of Hebei University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Gender: healthy adult male and female subjects with appropriate proportions; 2. Age: 18 years old or above (including 18 years old); 3. Weight: male subjects should not be less than 50.0 kg, female subjects should not be less than 45.0 kg, and body mass index BMI [weight (kg)/height ^2 (m^2)] is within the range of 19.0 kg/m^2~26.0kg/m^2 (including boundary value); 4. The subject can communicate well with the investigator, and understand and comply with the requirements of this study; 5.Subjects fully understand the content of the informed consent form and voluntarily sign it, and voluntarily participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Physical examination, vital sign measurement, electrocardiogram examination, and laboratory tests during the screening period, including [blood routine, urine routine, blood biochemistry, coagulation function examination, pregnancy examination (only for female subjects), serum virology examination], and the investigator judges that the abnormality is clinically significant; 2. Patients with a history of any clinically serious diseases such as respiratory system (including cor pulmonale, emphysema, and bronchial asthma), digestive system (with special attention to those with severe diarrhea in the week before the trial), cardiovascular system, blood and lymphatic system, psychiatric and nervous system (with special attention to the history of epilepsy), genitourinary system, endocrine system, liver, kidney, and metabolic abnormalities (including those with major diseases or major surgeries within 1 year before dosing) or any other disease history or physiological condition that can interfere with the test results; 3. Those who are currently suffering from the following diseases: myasthenia gravis, severe chronic obstructive pulmonary disease, acute angle-closure glaucoma, or angle-closure glaucoma; 4. Acute alcoholism with central nervous system suppression; 5. Past or existing respiratory depression or sleepwalking; 6. Those who are allergic to or intolerant to any of the ingredients in this product and excipients (lactose, corn starch, hydroxypropylcellulose, magnesium stearate), as well as those who are allergic to other benzodiazepines or have a history of drug, food or other allergies; 7. Those who cannot follow the uniform diet or have difficulty swallowing; 8. Those who have consumed too much tea, coffee or caffeinated beverages for a long time (more than 8 cups a day, 1 cup = 200 mL) in the past; 9. Those who have a history of alcohol addiction within 3 months before screening, that is, those who drink more than 14 units per week (1 unit = 17.7mL ethanol, that is, 1 unit = 357mL of beer with 5% alcohol or 43mL of liquor with 40% alcohol or 147mL of wine with 12% alcohol); or those who cannot abstain from alcohol during the study period; 10. Those who have used any prescription or over-the-counter drugs (including chemical drugs, medicated cosmetics, health care products, Chinese herbal medicines/Chinese patent medicines) within 2 weeks before screening; 11. Those who smoked = 5 cigarettes per day within 3 months before screening, or could not stop using any tobacco products during the trial; 12. Those who have participated in any drug clinical trial within 3 months before screening; 13. Those who have received vaccination within 4 weeks before screening, or those who plan to be vaccinated during the study period; 14. Those who have a history of drug abuse in the past five years, or have used drugs within 3 months before screening; 15. Those who donate or lose 200mL of blood or blood loss within 3 months before screening, or plan to donate blood or blood components during the study period or within 3 months after the end =of the study; 16. Pregnant, lactating females or females who plan to become pregnant during the trial, as well as female subjects who have a birth plan from 1 month before signing the informed consent form to 3 months after dosing, and are unwilling to take effective contraceptive measures or have an egg donation plan; Male subjects who have a fertility plan during the trial period and within 3 months after do
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2; | — |
Countries
China
Contacts
Public ContactYongchen Zhao
Affiliated Hospital of Hebei University
Outcome results
None listed