Reduced ability to operate under special conditions
Conditions
Interventions
T-R group:Take the test formulation in the first cycle and the reference formulation in the second cycle
R-Tgroup:Take the reference formulation in the first cycle and the test formulation in the second cycle
Sponsors
The First People's Hospital of Shanghai
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.1 Healthy male volunteers between the ages of 18 and 45 years (including the cut-off); 1.2 Weighing = 50 kg and with a body mass index (BMI) between 19 and 24 kg/m2 (inclusive of the cut-off); 1.3 Voluntarily signing the informed consent form; 1.4 Ability to maintain good communication with the investigator and to comply with the various requirements of the clinical trial;
Exclusion criteria
Exclusion criteria: 2.1 (Ask) Caffeinated food addicts (those who consumed caffeine = 100 mg per day within 1 month prior to the first dose, such as beverages like coffee, cola, strong tea, or foods like chocolate) and/or those who consumed caffeinated food or beverages within 3 days prior to the first dose, and those who could not be prohibited from consuming caffeinated food or beverages during the trial; 2.2 (ask) smokers and alcoholics (14 units of alcohol per week in the 3 months prior to the first dose: 1 unit = 10 ml of pure alcohol, i.e., approximately 285 ml of beer with 3.5% alcohol content, or 25 ml of spirits with 40% alcohol content, or approximately 83 ml of wine with 12% alcohol content; and an average of = 5 cigarettes per day in the 3 months prior to the first dose) and/or those who cannot abstain from smoking or alcohol; 2.3 (ask) persons with abnormal psychoneurological symptoms within 3 months prior to screening, including but not limited to the presence of tension, anxiety irritability, insomnia, headache, tremor, sensory hypersensitivity, and other central excitatory symptoms; 2.4 (Inquiries) Persons with a definite previous or current history of disease of the central nervous system, cardiovascular system, blood and lymphatic system, kidney, liver, digestive system, respiratory system, metabolic system, a history of psychiatric disorders, or other significant illness 2.5 (ask) persons with a clear previous history of drug allergy, or allergic body; a history of allergy to caffeine, or a clear history of allergy to any of the excipients in the test drug 2.6 (ask) a previous history of postural hypotension 2.7 (ask) those who have participated in a clinical trial of another clinical drug within 3 months prior to the first dose 2.8 (ask for consultation) use of any prescription medication within 4 weeks prior to the first dose, or use of any over-the-counter medication (vitamins, herbal-based supplements) within 2 weeks prior to the first dose, or consumption of foods that affect metabolism, such as grapefruit or beverages containing grapefruit and fruits such as grapefruit, dragon fruit, mango or related products within 2 weeks prior to the first dose; 2.9 (ask) who have donated or lost = 200 mL of blood within 3 months prior to the first dose, or who plan to donate blood during the trial; 2.10 Persons with positive results for any of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or syphilis spirochete antibody (TPPA); 2.11 Persons with a positive urine drug abuse screen (methamphetamine, ketamine, dimethylenedioxymethamphetamine, marijuana, morphine, cocaine); or persons with an alcohol breath test result greater than 0.0 mg/100 mL 2.12 (Ask) drug abusers or those who have used soft drugs (e.g., marijuana) within 12 months or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to the test 2.13 Persons with abnormal findings on physical examination, vital signs, electrocardiogram, chest X-ray, abdominal ultrasound, laboratory tests, etc. at the time of screening, which are judged by the study physician to be clinically significant 2.14 Those who have undergone surgery within 3 months prior to screening or are scheduled to undergo surgery during the study period; those who have undergone surgery that would affect drug absorption, distribution, metabolism, or excretion; 2.15 (ask) those who have a history of needle sickness and blood sickness or who ca
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Physical examination;Vital sign examination;Laboratory examination;12 lead electrocardiogram test; | — |
Primary
| Measure | Time frame |
|---|---|
| Plasma caffeine blood concentration; | — |
Countries
China
Contacts
Public ContactDing xueying
The First People's Hospital of Shanghai
Outcome results
None listed