Healthy subjects
Conditions
Interventions
A(T)(R)(R) group:First Cycle Oral Test Formulation (T), Second Cycle Oral Reference Formulation (R), Third Cycle Oral Reference Formulation (R)
B(R)(T)(R) group:First Cycle Oral Test Formulation (R), Second Cycle Oral Reference Formulation (T), Third Cycle Oral Reference Formulation (R)
C(R)(R)(T) group:First Cycle Oral Test Formulation (R), Second Cycle Oral Reference Formulation (R), Third Cycle Oral Reference Formulation (T)
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects fully understand the purpose, nature, method and possible adverse reactions of the test, voluntarily act as subjects, and sign informed consent; 2. Over the age of 18 (including 18 years old), the ratio of male to female is appropriate; 3. Weight: the weight of male subjects is not less than 50.0 kg, and the weight of female subjects is not less than 45.0 kg. Body mass index (BMI) [= weight kg/(height m)2] in the range of 19.0 to 28.0 (including 19.0 and 28.0); 4. The subjects have no history of chronic or serious diseases of cardiovascular, liver, kidney, blood and lymphatic, endocrine, immune, mental, nervous and gastrointestinal systems, and are in good overall health; 5. Vital signs examination (vital signs reference value range: Systolic blood pressure 90 ~ 139 mmHg (including boundary value), diastolic blood pressure 60 ~ 89 mmHg (including boundary value), pulse 60 ~ 100 beats/min (including boundary value), Body temperature 36.0 ~ 37.2 ? (including the boundary value) on the day of outpatient screening, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, preoperative four tests, coagulation function, 12-lead electrocardiogram), and the results showed no abnormality or no clinical significance; 6. The subjects are able to communicate well with the investigators and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of allergy to the components of Arbidol Hydrochloride Tablets; those who have experienced allergic reactions to two or more drugs, foods, etc.; 2. Those with a history of difficulty swallowing or any gastrointestinal disorders that may affect drug absorption; 3. Subjects with a history of surgery or trauma that may affect the safety of the trial or the pharmacokinetics of the drug, or those planning to undergo surgery during the study period; 4. Those who have used any medications or health products within 2 weeks prior to screening; 5. Subjects with a history of substance abuse within 6 months prior to screening; 6. Those who smoke more than 5 cigarettes per day within 3 months prior to screening, or cannot abstain from using tobacco products during the trial; 7. Subjects who consume more than 14 units of alcohol per week (1 unit = 17.7 mL ethanol, i.e., 1 unit = 357 mL of beer at 5% alcohol content or 43 mL of liquor at 40% alcohol content or 147 mL of wine at 12% alcohol content) within 3 months prior to screening, or cannot abstain from alcohol during the trial; 8. Those who consume excessive amounts of tea, coffee, and/or caffeine-containing beverages (more than 8 cups, 1 cup = 250 ml) daily within 3 months prior to screening; 9. Subjects who have consumed special diets affecting drug absorption, distribution, metabolism, and excretion, such as chocolate, caffeine-containing foods or beverages, or xanthine-containing foods or beverages within 48 hours prior to screening; 10. Subjects who have consumed pitaya, mango, grapefruit, sour orange, star fruit, or food or beverages prepared from them within 48 hours prior to screening; 11. Those who have participated in other drug clinical trials within 3 months prior to screening or did not personally attend the clinical trial; 12. Subjects who have donated blood including component blood or suffered significant blood loss (= 400 mL) within 3 months prior to screening, received blood transfusions or used blood products; 13. Subjects unable to tolerate venipuncture, with a history of fainting upon needle prick or sight of blood; 14. Those with special dietary requirements who cannot accept a unified diet; 15. Subjects planning to conceive or donate sperm within 6 months from the date of screening to the last administration of the investigational drug, unwilling or unable to take effective contraceptive measures; 16. Subjects with breath alcohol test results greater than 0.0 mg/100 mL or positive for substance abuse screening (morphine, methamphetamine, ketamine, N-methyl-D-aspartate, tetrahydrocannabinolic acid); 17. Other subjects deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters Cmax,;PK parameters AUC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Assessment; | — |
Countries
China
Contacts
Public ContactZhang Zhiqing
The Second Hospital of Hebei Medical University
Outcome results
None listed