None
Conditions
Interventions
A (T)(R) :First-cycle oral test formulation (T), second-cycle oral reference formulation (R)
B(R)(T):First-cycle oral test formulation (R), second-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) Subjects must fully understand the purpose, nature, methods of the trial and possible adverse reactions, volunteer to participate as a subject, and sign an informed consent form; 2) Age over 18 years old (including 18 years old), with appropriate gender ratio; 3) Weight: male subjects should weigh no less than 50.0 kg, female subjects should weigh no less than 45.0 kg. Body mass index (BMI) [=weight kg/(height m)^2] should be within the range of 19.0~28.0 (including 19.0 and 28.0); 4) Subjects without a history of chronic diseases or severe diseases in cardiovascular, liver, kidney, blood and lymphatic, endocrine, immune, mental, nervous, gastrointestinal systems, and overall good health status; 5) Life signs examination (reference value range for life signs: systolic blood pressure 90 ~ 139 mmHg (including boundary values), diastolic blood pressure 60 ~ 89 mmHg (including boundary values), pulse 60 ~ 100 times/min (including boundary values), body temperature 36.0 ~ 37.2°C (including boundary values) on the day of outpatient screening), physical examination, clinical laboratory tests (complete blood count, urine routine, blood biochemistry, preoperative four-item test, coagulation function, 12-lead electrocardiogram), with no abnormal results or clinically insignificant abnormalities; 6) Subjects who can communicate well with researchers and understand and comply with all requirements of this 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) Subjects with lactose intolerance (those who have experienced diarrhea after drinking milk); 15) Those with special dietary requirements who cannot accept a unified diet; 16) Subjects who plan 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; 17) 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); 18) Other subjects deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration Cmax;Area Under the Curve AUC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Maximum Plasma Concentration;Elimination Half-life; | — |
Countries
China
Contacts
Public ContactZhang Zhiqing
The Second Hospital of Hebei Medical University
Outcome results
None listed