Insomnia
Conditions
Interventions
Fasting A group:10 mg of test preparation T in the first cycle, 10 mg of reference preparation R in the second cycle, 10 mg of test preparation T in the third cycle and 10 mg of reference preparation
Post-prandial C group:10 mg of test preparation T in the first cycle, 10 mg of reference preparation R in the second cycle, 10 mg of test preparation T in the third cycle and 10 mg of reference prepar
Fasting B group:10 mg of test preparation R in the first cycle, 10 mg of reference preparation T in the second cycle, 10 mg of test preparation R in the third cycle and 10 mg of reference preparation
Post-prandial D group:10 mg of test preparation R in the first cycle, 10 mg of reference preparation T in the second cycle, 10 mg of test preparation R in the third cycle and 10 mg of reference prepar
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age = 18 years, both sexes 2) Body weight = 50.0 kg for male volunteers and = 45.0 kg for female volunteers with a body mass index (BMI) between 19 ~ 26 kg/m2, including the threshold; 3) Volunteers voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Persons with any previous or current clinically serious disease of the circulatory, endocrine, neurological, digestive, respiratory, genitourinary, haematological, immunological, psychiatric and metabolic abnormalities or any other disease that can interfere with the test results (e.g. severe respiratory insufficiency, sleep apnoea syndrome, severe, acute or chronic hepatic insufficiency, muscle weakness, etc.); 2) a history of allergy to drugs, food or other substances 3) have undergone surgical procedures within 4 weeks prior to the trial or are scheduled to undergo surgical procedures during the study 4) those who have used any medication or supplements (including herbal remedies, etc.) within 14 days prior to the trial 5) those who have received a vaccination within one month prior to the trial or are scheduled to receive a vaccination during the trial 6) any drug that inhibits or induces hepatic metabolism of drugs within 30 days prior to the trial (e.g. inducers - barbiturates, rifampicin, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics , verapamil, fluoroquinolones, antihistamines, ketoconazole, fluvoxamine, ciprofloxacin); 7) those who participated in any clinical trial and took any clinical trial drug within the 3 months prior to the trial 8) those who have donated blood or lost a significant amount of blood (= 200 mL, excluding blood loss during menstruation in women), received a blood transfusion or used blood products within 3 months prior to enrolment 9) those who cannot tolerate venipuncture and/or have a history of blood or needle sickness 10) pregnant or breastfeeding women and those who are unable to use one or more non-pharmaceutical contraceptive measures during the volunteer trial 11) those who have used oral contraceptives within 30 days prior to the trial, or long-acting oestrogen or progestin injections or implants within 6 months prior to the trial 12) those with previous or current blurred/returned vision 13) those with special dietary requirements who are unable to comply with a uniform diet 14) Those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day 15) who have consumed or plan to consume any food or beverage containing caffeine (e.g. coffee, strong tea, chocolate, etc.) or xanthine rich ingredients (e.g. sardines, animal liver, etc.) or beverages within 48 hours prior to the first dose of study drug 16) Those who have consumed or plan to consume grapefruit or grapefruit-related citrus fruits (e.g. lime, grapefruit), poplar, papaya, pomegranate or fruit products of the above within 14 days prior to the first dose of study drug 17) smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to the trial or those who were unable to stop using any tobacco-based products during the trial 18) alcoholics or regular drinkers of alcohol in the 6 months prior to the trial, i.e. those who consume more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine) or those who are unable to stop using any alcohol-containing product during the trial 19) Substance abusers or those who have used soft drugs (e.g. cannabis) in the 3 months prior to the trial or hard drugs (e.g. cocaine, phencyclidine, etc.) in the 1 year prior to the trial 20) those who have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration;vital signs;adverse events;laboratory test;Physical examination;Twelve-lead electrocardiogram;AUC0-t;AUC0-8;AUC_%Extrap; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak concentration;?z;T1/2z; | — |
Countries
China
Contacts
Public ContactGuoping Yang/Zuojun Li
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed