healthy person
Conditions
Interventions
1st group:0.025 mg/kg
2nd group:0.05 mg/kg
3th group:0.075 mg/kg
4th group:0.10 mg/kg
5th group:0.20 mg/kg
6th group:0.30 mg/kg
7th group:0.40 mg/kg
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Chinese healthy volunteer may be included in the study if he/she meets all of the following inclusion. 1. According to the complete history, including physical examination, vital signs (BP, PR, RR), 12- lead ECG, clinical laboratory tests; 2. Healthy males and females 18 to 45 years of age; 3. Subject has a Body Mass Index (BMI) of 19 to 24 kg/m2; 4. Subjects will sign informed consent voluntary;
Exclusion criteria
Exclusion criteria: 1. Subject has any evidence of abnormal and clinically significant medical examination; 2. Subject has any evidence of the disease associated with any clinically relevant; 3. Subject has gastrointestinal, liver, kidney, respiratory system, cardiovascular, metabolic, immune and other diseases; 4. Subject has taken gastrointestinal surgery (appendectomy excluded); 5. Subject has myasthenia gravis 6. Subject has the central nervous system diseases (such as epilepsy), mental disorders or other neuropsychiatric disorders; 7. Subject has orthostatic hypotension, dizziness or vertigo history; 8. Subject has chronic or acute infection; 9. Subject has a history of allergy / hypersensitivity (including drugs or other substances); 10. Subject is taking any other drugs within one month prior to the study; 11. Subject is taking any other drugs during the administration within two months prior to the study or other research trial; 12. Smokers (more than 10cigarettes or 3cigars or 3 pipe tobaccos per day); 13. Subject who can not quit smoking during the trial; 14. alcohol abuse (more than 60 g / day); 15. Drug abuse; 16. Blood donation (donate more than100mL before 4 weeks or during the period of the study); 17. Subject is taking excessive physical activity (1 week prior to the study or during the study); 18. Subject has any clinically significant laboratory values outside the reference range; 19. Subject does not comply with the diet program of the research centers; 20. The baseline was significantly prolong at the QT / QTc period; 21. Subject has a history of presence of additional risk of TdP (such as heart failure, hypokalemia, family history of long QT syndrome); 22. Unwilling to contracept or sexual partner is reluctant to use contraception During the test; 23. A screening or baseline ECG abnormalities (clinical significance) or abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm; blood oxygen saturation less than 95%); 24. Subject has contraindications of benzodiazepine class of drugs, flumazenil, anesthetic allergies, or the application of such drugs; 25. Subject is taking any long-term of benzodiazepines and shows signs of drugs (such as insomnia, anxiety, spasms) or screening period were positive urine drug screening; 26. Mallampati score (Markov rates) of 3 or 4; 27. Any other factors which the investigators considered that not suitable for the subject to enter the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE;MOAA/S scores;BIS index;Dose-effect relationship; | — |
Secondary
| Measure | Time frame |
|---|---|
| The pharmacokinetic; | — |
Countries
China
Contacts
Public ContactYimin Cui
Peking University First Hospital
Outcome results
None listed