None listed
Conditions
Interventions
Fasting administration group:Day 1 to 6: at about 07:30, 15:30, 23:30, take 60mg (2 tablets) of hydroxynitone capsule on an empty stomach with 200mL water
Day 7: Take 60mg (2 tablets) of hydroxynitone capsule orally on an empty stomach with 200mL water at around 07:30 Day 10 to 19: at about 07:30, entecavir capsu
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Gender: Chinese healthy male subjects; 2. Age: 18-40 years old, the age difference is not more than 10 years old; 3. Weight: >=50kg; BMI [=weight kg/(height m2)] between 19-24; 4. The subjects (or their partners) have no plans to become pregnant during the trial and within 6 months after the trial, and voluntarily take effective physical contraception and have no plans to donate sperm; 5. Have a detailed understanding of the nature, significance, possible benefits, possible inconvenience and potential dangers of the trial before the trial, and voluntarily participate in this clinical trial, able to communicate well with investigators, and comply with the requirements of the entire study, and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. (Consultation) Those who have participated in any other clinical trial within three months before the trial; 2. (Consultation) Any disease that may affect the safety of the test or the internal process of the drug, including but not limited to: heart, liver, kidney, endocrine, digestive tract Those with previous or existing diseases of the immune system and respiratory system [especially those with cardiovascular diseases, including those at risk of cardiovascular diseases, any gastrointestinal diseases affecting drug absorption (such as symptoms of irritable bowel syndrome, intestinal diseases or inflammatory bowel disease history), active pathological bleeding (such as peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczema dermatitis, asthma, etc.]; 3. (Consultation) Allergic constitution: if there are two or more drugs, food allergy history (including test drugs), lactose intolerance; 4. (Inquiries) Have used any drugs that inhibit or induce the metabolism of liver to drugs (common liver enzyme inducers: barbiturates (phenobarbital is the most common), carbamazepine, amlumide, griseofulvin, trimethoprim, phenytoin, glumit, rifampicin, dexamethasone) within 28 days before taking the study drug; Common liver enzyme inhibitors: promethazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide); Or those who have used any medicine (including Chinese herbal medicine) and health care products within 14 days before the first administration; 5. (Consultation) Those who have special requirements for food, cannot follow the unified diet (such as intolerance to standard food, etc.) or have difficulty swallowing; 6. (Consultation) Those who cannot tolerate venipuncture and/or have a history of blood and needle sickness; 7. (Consultation) Those who have consumed too much tea, coffee or caffeinated drinks (more than 8 cups a day, 1 cup=250mL) for a long time; Or those who ingest any food or drink containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first administration of drugs, and other special diets that affect the absorption, distribution, metabolism and excretion of drugs; 8. (Consultation) Previous alcoholism (that is, men drink more than 28 standard units per week and women drink more than 21 standard units per week (1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); Or drink regularly (more than 14 standard units per week) within 6 months before the test; Or those who have taken any alcoholic products within 24 hours before the first administration of drugs in the study; 9. (Consultation) Those who have donated blood or massive bleeding (more than 450 mL) within 3 months before the first administration of drugs in the study, or plan to donate blood or blood components during the study or within 3 months after the end of the study; 10. (Consultation) Acute disease occurred in the pre-study screening stage or before the study medication; 11. (Consultation) Those who have taken any food or drink (such as grapefruit, mango, pitaya, grape juice, orange juice, etc., which contain rich flavonoids or citrus glycosides) that can induce or inhibit liver metabolism enzymes within 24 hours before the first administration of the drug; 12. (Consultation) Those who have undergone surgery within three months before the screening period, or who plan to undergo surgery during the study period, and those who have undergone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of hydronidone and entecavir in plasma by HPLC-MS/MS; | — |
Countries
China
Contacts
Public ContactShaojun Shi
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed