None
Conditions
Interventions
A group:Two-periods, dexmedetomidine nasal spray 1 shot (25ug) or dexmedetomidine injection 25ug iv or relative placebo for each period
B group:dexmedetomidine nasal spray 3 shots (75ug) or relative placebo
C group:dexmedetomidine nasal spray 5 shots (125ug) or relative placebo
D group:dexmedetomidine nasal spray 6 shots (150ug) or relative placebo
E group:dexmedetomidine nasal spray 7 shots (175ug) or relative placebo
F group:dexmedetomidine nasal spray 8 shots (200ug) or relative placebo
Sponsors
Beijing Shijitan Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1 sex: male and female healthy subjects; 2 Age: 18~65 years old (including the boundary value); 3 Weight: Both male and female subjects should not be less than 50.0kg, and the body mass index [BMI= weight (kg)/ height 2(m2)] is in the range of 19.0~26.0kg/m2 (inclusive); 4. Subjects must give informed consent to this study before the experiment, and voluntarily sign a written informed consent form; 5. Subjects can communicate well with researchers, use nasal spray devices correctly after training, and complete the research according to the research regulations.
Exclusion criteria
Exclusion criteria: 1) allergic to dexmedetomidine hydrochloride and its related compounds and accessories, or allergic to two or more drugs (or foods); 2) Those who can't follow the unified diet (such as intolerance to standard meals); 3) those who can't tolerate venipuncture and have a history of needle fainting and blood fainting; 4) Having a serious medical history of cardiovascular disease, liver disease, kidney disease, endocrine disease, metabolism disease, digestive tract disease, blood system disease, respiratory system disease, infection disease, malignant tumor disease and mental disorder, or having the above-mentioned diseases; 5) Those who have a history of nasal diseases or diseases judged by researchers to be clinically significant: a) The history has symptoms such as long-term nasal congestion, runny nose, itchy nose, headache and nosebleed; B) Asthma, aspirin stress, chronic respiratory diseases, etc. C) Previous history of nasal surgery, trauma, or severe rhinitis and sinusitis, which affects drug absorption; D) Other abnormal nasal cavity structures and nasal mucosa that affect drug absorption; 6) Individuals with airway hyperresponsiveness, such as those who have previously or currently suffered from chronic obstructive pulmonary disease, asthma, sleep apnea syndrome, etc; 7) During the screening period, the heart rate (pulse) is 60 beats/min, or there is a history of serious arrhythmia such as degree II or above atrioventricular block (excluding patients using pacemakers); 8) The oxygen saturation value is 92% in the non-oxygen inhalation state during the screening period; 9) Systolic blood pressure in screening period is 90mmHg;; 10) Screening patients who have undergone major surgery within 6 months before the screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect the absorption, distribution, metabolism and excretion of drugs (except appendicitis surgery); 11) Physical examination, vital sign monitoring, blood oxygen saturation measurement, electrocardiogram examination, chest X-ray examination, nose examination, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function) during the screening period, and the researcher judges that the abnormality has clinical significance; 12) The examination results of hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody and human immunodeficiency virus antibody are abnormal and have clinical significance; 13) Those who have been drinking too much tea, coffee or caffeinated drinks for a long time (within 3 months before screening) (more than 8 cups a day, 1 cup =200mL); Or ingesting any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first medication; 14) Those who ingest any beverage or food rich in xanthine or grapefruit or other ingredients that affect the absorption, distribution, metabolism and excretion of drugs within 48 hours before the first medication; 15) Have used any drugs (such as anesthetics, sedatives, hypnotics, opioids, neuromuscular blockers, etc.) that interact with dexmedetomidine hydrochloride within 30 days before screening; 16) Those who have used long-acting estrogen or progesterone injections or implanted tablets within 6 months before the trial; Those who have used short-acting contraceptives within 30 days before the trial; 17) Those who have used any prescription drugs, over-the-coun
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peak concentration (Cmax);area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0–t);area under the concentration-time curve from time 0 to 8 (AUC0–8) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;Apparent distribution volume (Vz) ;Elimination half-life (t1/2z);Average residence time (MRT);Apparent clearance rate (CL);Absolute bioavailability (f); | — |
Countries
China
Contacts
Public ContactWANG Xinghe
Beijing Shijitan Hospital affiliated to Capital Medical University
Outcome results
None listed