diabetes
Conditions
Interventions
Fasting medium dose:The first cycle: D1 fasting, a single oral high specification HDM1002 (200 mg/ tablet) 1 tablet
The second cycle: D8 fasting, a single oral medium HDM1002 (100 mg/ tablet) 2 tablets
The third cycle: D15 After eating a high-fat meal, take one tablet of high-specification HDM1002 (200 mg/ tablet) orally once.
fasting high dose:The first cycle: D1 fasting, a single oral medium HDM1002 (100 mg/ tablet) 2 tablets
The second cycle:D8: After eating a high-fat meal, take one tablet of high specification HDM1002 (200 mg/ tablet) orally once
The third cycle: D15 fasting, a single oral high specification HDM1002 (200 mg/ tablet) 1 tablet.
fed high dose:The first cycle: D1 After eating a high-fat meal, take one tablet of high-specification HDM1002 (200 mg/ tablet) orally once
The second cycle: D8 fasting, a single oral high specification HDM1002 (200 mg/ tablet) 1 tablet
The third cycle: D15 fasting, a single oral medium HDM1002 (100 mg/ tablet) 2 tablets.
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The investigator considered the subject's overall health good, Based on medical history, clinical lab tests, vital signs, 12-lead ECG, and physical exam during the screening period. 2. Aged 18 - 45 (inclusive), regardless of gender. 3. Males weigh >=50.0 kg, females weigh >=45.0 kg, with a BMI of 19.0 -30.0 kg/m² (inclusive). 4. Signed an informed consent form (ICF) before the trial, fully understanding its content, process, and potential adverse reactions. 5.The subject can communicate well with the investigator and understands and complies with the study's requirements. 6. Fertile female subjects from ICF signing to 30 days post-final dosing, and male subjects from ICF signing to 90 days, must not plan pregnancy, use highly effective contraception, and refrain from sperm/egg donation during these periods.
Exclusion criteria
Exclusion criteria: Subjects meeting any exclusion criteria must not be enrolled: 1. Those who show clinical significance of the following diseases during screening, including but not limited to: diseases related to the respiratory system, circulatory system, cardiovascular system, digestive system, hematological system, endocrine system, immune system, skin system, nervous system, and ophthalmic system. 2. The subjects have a history or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenoma type 2 (MEN2), or have a calcitonin level of >= 50 ng/L during the screening period. 3. Have a history of chronic pancreatitis or an acute pancreatitis attack within 3 months before screening. 4. Have a history of acute cholecystitis attack within 3 months before screening. 5. The investigator determines that the subject has a disease or condition that causes difficulty in swallowing, affects gastric emptying, or impairs the absorption of nutrients in the gastrointestinal tract, such as undergoing weight loss surgery or other gastric resection, irritable bowel syndrome, dyspepsia, etc. 6. The subjects have a clinically significant history of cardiovascular and cerebrovascular diseases within 6 months before screening or at the time of admission, including: recurrent or frequent syncope or vasovagal syncope; hypertension or hypotension; coronary heart disease; severe peripheral arterial circulatory disorder; risk factors for torsades de pointes ventricular tachycardia (such as heart failure, cardiomyopathy, or family history of long QT syndrome); sick sinus syndrome, second or third degree atrioventricular block, incomplete or complete bundle branch block. 7. Major surgery within 6 months before screening, unhealed surgical incisions, or planned surgeries during the study. 8. Past surgeries or planned study - period surgeries affecting drug ADME. 9. History of specific allergies, allergic constitution, or allergy to HDM1002 or any excipient. 10. Blood donation or significant blood loss (>=400mL) within 3 months before screening. 11. Select those who consumed an average of more than 14 standard units of alcohol per week over the past 3 months (1 standard unit contains 14g of alcohol, such as 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine); or those who consumed alcohol from the time of screening until the first administration of the drug; those with positive alcohol content test results at the baseline period; and those who were unwilling to stop drinking alcohol or any alcoholic products during the trial period. 12. Excessive alcohol, smoke, tea, coffee, or caffeine consumption within 3 months before screening; unwillingness to discontinue during the trial. 13. Select those who smoked at least 5 cigarettes per day for the previous 3 months; or those who were still smoking from the time of screening until the first administration of the drug; or those who were unable to stop using any tobacco products during the trial. 14. History of drug abuse (e.g., morphine, ketamine, cocaine) or positive urine drug test at screening. 15. Use of prescription, OTC drugs, supplements, or herbs within 2 weeks before study drug administration. 16. Use of liver enzyme or transporter - activity - altering drugs within 28 days before study drug intake or planned use during the study. 17. Special dietary needs incompatible with the study diet. 18. Consumption of grapefruit - containing products within 7 days before first dosi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentrations of tenofovir alafenamide fumarate (TAF) (Cmax);Area under the curve for the time from administration to the lowest detectable blood concentration(AUC0-t);Area under the curve for the time from drug administration to extrapolation to infinity(AUC0-8); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak concentration(Tmax);Elimination rate constant(?z);Terminal terminal half-life was eliminated(t1/2z);Residual area percentage(AUC_%Extrap); | — |
Countries
China
Contacts
Public ContactYing Wang
Hangzhou First People's Hospital
Outcome results
None listed