Herpes simplex virus
Conditions
Interventions
Fasting group:Take acyclovir tablet test preparation or reference preparation on an empty stomach
Postprandial group:Take acyclovir tablet test preparation or reference preparation after meal
Sponsors
Taizhou Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age: healthy males aged 18-65 years and non-pregnant non-lactating females (including cut-off); 2.Weight: male need >=50.0 kg, female need >=45.0 kg, [BMI= weight (kg)/height 2 (m^2)] in 19.0~26.0 kg/m^2 (including the critical value); 3.Physical examination, vital signs examination, electrocardiogram examination, clinical laboratory examination during screening period and other auxiliary examination results showed normal or abnormal clinical significance judged by the investigator; 4.Screening (women from 2 weeks before the screening day) to 3 months after the end of the study to take effective contraception, and in the next 3 months no fertility plans or sperm donation, egg donation plan; 5.Fully understand the content of the informed consent and sign it voluntarily to participate in the study; 6.Able to communicate well with researchers and complete research according to research protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Have a history of allergy to acyclovir or valaciclovir drugs or one of their active ingredients or excipients; Have a history of allergy to two or more drugs, foods, etc.; Those who are allergic; 2.People who have difficulty swallowing, or lactose intolerance (have had diarrhea from drinking milk), or have special dietary requirements and cannot accept a uniform diet; 3.Have any chronic or severe diseases of endocrine system, urinary system, digestive system, blood and lymphatic system, respiratory system, cardiovascular system, nervous system, mental disease, musculoskeletal system, skin system and other systems mentioned above, and the study doctor judges that the abnormalities are clinically significant; 4.Those who consumed excessive (more than 8 cups a day, 1 cup =250mL) strong tea, strong coffee and/or caffeinated beverages in the 3 months prior to screening, or consumed any food or beverage containing or metabolically producing caffeine or rich in xanthines (such as coffee, tea, chocolate, etc.) within 48 hours prior to the start of the trial, Or do not agree to stop taking these foods or drinks throughout the trial; 5.Those who consumed more than 14 units of alcohol per week in the 6 months prior to screening (1 unit of alcohol =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) or could not abstaining from alcohol from the screening date to the end of the study; 6.Smoking more than 5 cigarettes per day in the 3 months prior to screening, or not agreeing to stop using any tobacco products between the screening date and the end of the study; 7.People who have used any drugs (including prescription drugs, over-the-counter drugs, vitamin supplements or Chinese herbs) or health products in the 14 days prior to screening; 8.Any drug that inhibits or induces liver metabolism of drugs or interacts with acyclovir (e.g., inducers - barbiturates, carbamazepine, phenytoin, rifampin) used within 30 days prior to screening; Inhibitors -SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungal drugs, HIV protease inhibitors, etc.; Prosulfasol, theophylline, mycophenolate metabolites, zidovudine, interferon or methotrexate (intrathecal), etc.); 9.History of drug abuse in the 6 months prior to screening, use of drugs in the 3 months prior to screening; 10.Other drug or device clinical investigators enrolled within 3 months prior to screening; 11.Vaccinated within 1 month prior to screening; 12.Blood donation (including component blood) or significant blood loss (=400 mL) within 3 months prior to screening, receiving transfusions or using blood products, or planning to donate blood during the study period or within one month after the study ends; 13.Patients who had surgery within 3 months prior to screening, or who planned to have surgery during the study period, or who had surgery that would affect drug absorption, distribution, metabolism, or excretion; 14.A special diet (including grapefruit, chocolate, tea, cola, or any food or beverage containing caffeine, alcoholic beverage, or other food or beverage that affects the absorption, distribution, metabolism, or excretion of the drug) cannot be guaranteed from 48 hours before dosing until the end of the study; 15.Patients who cannot tolerate venipunction, have a history of fainting needles and fainting blood, and fail to pass venous assessment; 16.Female subjects with positive pregnancy test results during the screening pe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration, peak time, AUC0-T, AUC0-8, elimination half-life, elimination rate constant, and percentage of extrapolation from AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs examination (24h±30min after administration, including body temperature, pulse and blood pressure);Physical examination (skin mucosa, superficial lymph nodes, head, neck, chest, abdomen, spine/limbs, etc.);12-lead electrocardiogram, laboratory test (blood biochemistry, blood routine, urine routine, coagulation function, infectious disease screening, etc.), pregnancy test (female only); | — |
Countries
China
Contacts
Public ContactXu Luwei
Taizhou Hospital of Traditional Chinese Medicine
Outcome results
None listed