Herpes zoster, herpes simplex virus infection
Conditions
Interventions
Fasting test TR group:The first cycle involves oral administration of 0.5g of the test preparation (T) on an empty stomach with 240mL of water
Cross administration after 3 days
In the second cycle, 0.5g of the reference preparation (R, Vedex) was taken orally on an empty stomach with 240mL of water.
Fasting test RT group:The first cycle involves taking 0.5g of the reference preparation (R, Vedex) orally on an empty stomach and delivering 240mL of water
In the second cycle, 0.5g of the test preparation (T) was orally administered on an empty stomach with 240mL of water.
Fed test TR group:Oral administration of the test preparation (T) 0.5g and 240mL of water after the first high-fat meal
Take 0.5g of the reference preparation (R, Vedex) orally after the second high-fat meal, with 240mL of water delivered.
Fed test RT group:Take 0.5g of the reference preparation (R, Vedex) orally after the first high-fat meal, with 240mL of water delivered
Oral administration of the test preparation (T) 0.5g and 240mL of water after the second high-fat meal.
Sponsors
Affiliated Hospital of Hebei University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.The subject is fully aware of the purpose, nature, methodology, and potential adverse effects of the trial, volunteers to be a subject, and signs an informed consent form prior to the start of any study procedures; 2.Healthy male and female subjects between 18 and 50 years of age (including 18 and 50 years of age) with an appropriate gender ratio; 3.Men weighing >=50.0 kg and women weighing >=45.0 kg, with a body mass index (BMI) in the range of 19.0 to 26.0 kg/m^2 (including threshold values); 4.No pregnancy or sperm/egg donation within 6 months from the date of informed consent to the date of the last dose, and voluntary use of effective contraception (non-pharmacological contraception during the trial period), and no unprotected sexual intercourse in the 14 days prior to the first dose in the case of female subjects; 5.The subject has no history of chronic or serious diseases of the cardiovascular, hepatic, renal, respiratory, hematologic and lymphatic, endocrine, immunologic, psychiatric, neurologic, or gastrointestinal systems, and is in good general health. 6.Subjects are able to communicate well with the investigator and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity to vasiclovir, acyclovir, or any of the ingredients in this preparation, or anaphylaxis; 2.Diseases that have occurred or are occurring prior to Screening that require exclusion of clinical abnormalities, including, but not limited to, neurological/psychiatric, respiratory, cardiovascular, gastrointestinal (history of dysphagia or any gastrointestinal disease that interferes with absorption of medications), hematological and lymphatic, urologic, endocrine, and immune system disorders; 3.History of postural hypotension, needle-sickness or blood-sickness; 4.Positive for Hepatitis B Surface Antigen, or Hepatitis C Antibody, or Syphilis Antibody, or HIV Antibody; 5.Those who have been vaccinated within 2 weeks prior to the trial or plan to be vaccinated during the trial; 6.Anyone who has used any medication (including herbal remedies) for any reason within 2 weeks prior to the trial; 7.Use of any drug that inhibits or induces hepatic metabolism of a drug (e.g., inducers - barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole; depressants - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within the last 30 days prior to the trial; 8.Blood loss of 400 mL within 3 months prior to the trial, or who intend to donate blood and receive blood products (including blood components) during the trial or within 3 months after the completion of the trial; 9.Surgery within 1 month prior to the trial; 10.Pregnant or breastfeeding women or those who plan to give birth within 6 months; 11.History of substance abuse within 1 year prior to the trial; 12.Persons who smoked more than 5 cigarettes per day in the 3 months prior to the trial or who were unwilling to stop using any tobacco products during the trial; 13.Drinking more than 14 units of alcohol per week (1 unit = 17.7mL of ethanol, i.e., 1 unit = 357mL of beer at 5% alcohol or 43mL of white wine at 40% alcohol or 147mL of grape wine at 12% alcohol) in the 3 months prior to the screening period, or who are unable to abstain from alcohol during the trial; 14.Excessive daily consumption of tea, coffee, or caffeinated beverages (more than 8 cups, 200 mL each); 15.Anyone with food allergies or special dietary requirements who cannot comply with a uniform diet; 16.Participation in any other clinical trial within 3 months prior to the trial; 17.Abnormalities of clinical diagnostic significance detected by laboratory tests within 2 weeks prior to the test; 18.Those with clinically significant abnormalities in the pre-test ECG, physical examination or vital signs; 19.Lactose intolerant (those who have experienced diarrhea from drinking milk); 20.Those who have had strenuous exercise 2 weeks prior to the test; 21.Lipid panel (total cholesterol (TCH), triglycerides (TG)) and liver function panel (alkaline phosphatase (ALP)) exceeding the upper limit of the reference range; 22.Any other situation that the researcher deems inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactYongchen Zhao
Affiliated Hospital of Hebei University
Outcome results
None listed