Anxiety disorder
Conditions
Interventions
Group A:Period 1: lorazepam 2mg
Period 2: placebo 2mg
Group B:Period 1: placebo 2mg
Period 2: lorazepam 2mg
Sponsors
Shanghai Xuihui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The subjects sign the informed consent form, fully understand the research content, process, and possible adverse reactions, and indicate the signing date; 2. Age range of 18 to 45 years old (including 18 and 45 years old), male or female; 3. BMI between 18-26 kg/m^2 (including 18 and 26) and weight >= 50.0 kg; 4. Participants must agree to comply with the prescribed contraceptive requirements during the study period and within 3 months after the last dose; 5. General good health condition (evaluated by researchers based on medical history, surgical history, complete physical examination, vital sign measurements, laboratory tests, and 12 lead electrocardiogram results), with no evidence of active or chronic disease; 6. Participants must be willing to understand and comply with the research procedures and limitations, have the ability to complete the study as planned, and be able to communicate effectively with researchers;
Exclusion criteria
Exclusion criteria: 1. Those who have special dietary requirements and cannot follow a uniform diet; 2. Current or former drug users, or individuals who have tested positive for drug abuse screening; 3. Current or former alcoholics (drinking more than 14 standard units per week. 1 standard unit contains 14g of alcohol, such as 360mL of beer or 45mL of 40% spirits or 150mL of wine), or those who have a positive breathalyzer test for alcohol; 4. Smoking more than 10 cigarettes per day; Within 48 hours prior to the first administration of the investigational drug, consuming food or beverages containing alcohol and/or xanthine/caffeine; 6. Have participated in any other clinical studies (such as vaccines, new drugs, biological devices, blood products, etc.) within 90 days before the start of the study, or plan to participate in other studies during the study period; 7. The results of infectious disease screening in the screening period or the baseline period are positive, including the detection of hepatitis B B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, HIV antibody, and treponema pallidum antibody; 8. Non physiological blood loss of = 200 ml within 90 days before medication (including trauma, blood collection, blood donation, etc.), or planned to donate blood during the study period or within 30 days after the last dose; 9. Use any prescription or over-the-counter medication, any vitamin product, or herbal medicine within 14 days prior to the first administration of the investigational drug or at least 5 half lives of the drug (whichever is longer); 10. Use of central nervous system drugs such as anti anxiety, anti depression, sedative and hypnotic drugs (including but not limited to barbiturates and benzodiazepines) within 6 months prior to the first administration of the investigational drug; 11. Any known disease or condition that may interfere with drug absorption, distribution, metabolism, or excretion, as determined by the researcher (such as difficulty swallowing or gastrointestinal diseases that affect drug absorption); 12. There is a history of serious clinical diseases, such as cardiovascular, liver, endocrine, gastrointestinal, metabolic, neurological, pulmonary, endocrine, psychiatric or neoplastic diseases, including acute angle closure glaucoma, myasthenia gravis, respiratory dysfunction (such as COPD, sleep apnea syndrome), etc., or clinically significant diseases, conditions or other evidence that the researcher believes may pose a risk to the safety of the subjects or interfere with the conduct, conduct or completion of the study; 13. Those who have undergone significant interventional treatment or hospitalization (such as surgery, abdominal puncture, etc.) within the 6 months prior to the study, or those who plan to undergo surgery during the study period; 14. Those who have severe visual impairment, high myopia, high astigmatism, strabismus, diplopia, ophthalmoplegia or other eye diseases that the researcher determines affect the assessment of eye scanning movement; 15. The subject has a lifelong history of suicide attempts (including actual attempts, interrupted attempts, or abandoned attempts), or has suicidal ideation within the past 6 months; During the study period until one week after the last administration, the subjects plan to drive vehicles, operate machinery, or work at heights. 17. History of past or suspected hypersensitivity reactions or allergic reactions to the components of the investigational drug; 18. Fem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale alertness;Saccadic peak velocity;Saccadic latency;Saccadic inaccuracy;smooth pursuit eye movement gain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of Lorazepam;Cmax;Tmax;t1/2;AUC0-t;AUC0-8;CL/F;Vz/F;MRT0-t;MRT0-8; | — |
Countries
China
Contacts
Public ContactQian Chen
Shanghai Xuihui Central Hospital
Outcome results
None listed