Chronic hepatitis B
Conditions
Interventions
Fasting 1 Group (T-R-R):subjects in the T-R-R group received 25mg TAF of the test formulation in a fasting single dose in the first cycle, 25mg TAF of the reference formulation in a fasting single dos
Fasting 2 Group (R-T-R):subjects in the R-T-R group received 25mg TAF of the reference formulation in a fasting single dose in the first cycle, 25mg TAF of the test formulation in a fasting single dos
Fasting 3 Group (R-R-T):subjects in the R-R-T group received 25mg TAF of the reference formulation in a fasting single dose in the first cycle, 25mg TAF of the reference formulation in a fasting singl
Fed 1 Group (T-R-T-R):The subjects were fasting (fasting without water) for at least 10h before the test, were forbidden to drink water from 1h before to 1h after the drug on the day of administration
Sponsors
Hangzhou Red Cross Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Healthy subjects, both male and female, 18~65 years old (including boundary value); (2) Male weight >=50kg, female weight >=45kg, body mass index of 19.0~26.0 kg/m^2 (including boundary value, calculation formula = weight/height^2); (3) The subjects signed the informed consent form before the trial and voluntarily participated in the trial.
Exclusion criteria
Exclusion criteria: 1) Those with clinically significant (including but not limited to) heart, liver, kidney, gastrointestinal, gallbladder, endocrine, cardiovascular, neurological, psychiatric, respiratory, immune, blood, hematopoietic and other systemic diseases judged by the investigator; and those who have a history of serious diseases of the above organs or systems, which may endanger the safety of subjects or affect the results of the study; 2) Those who have abnormal vital signs, physical examination, laboratory tests (blood routine, urine routine, blood biochemistry), electrocardiogram, and chest X-ray examination and are judged to be clinically significant by the investigator; 3) Patients with rare genetic problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption; 4) Patients with at least one abnormal test of hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B e antigen, hepatitis B e antibody, hepatitis B core antibody, hepatitis C antibody (IgM + IgG), AIDS antigen and antibody, and syphilis-specific antibody at least one abnormality with clinical significance; 5) Those who have a history of food or drug allergy or other allergic diseases (asthma, urticaria, eczematoid dermatitis, etc.) judged by the investigator to be clinically significant, or those who have been allergic to tenofovir alafenol fumarate tablets and their excipients (a lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talcum powder and iron oxide yellow); 6) Those who are unable to comply with the uniform dietary regulations (such as intolerance to standard meals); 7) Dysphagia; 8) Those who cannot tolerate venipuncture or have difficulty in venous blood collection, or have a history of fainting needle and blood sickness; 9) Use of any drugs that interact with the trial drug or change the activity of liver enzymes within 4 weeks before screening, such as anticonvulsants (carbamazepine, phenobarbital, phenytoin), antimycobacterial drugs (rifabutin, rifampicin and rifapentine), antifungal drugs (itraconazole, ketoconazole) and St. John's wort, etc.; or those who have used any prescription drugs, over-the-counter drugs, Chinese medicines and health products within 7 days before screening; 10) Those who have consumed caffeine food or beverages (such as coffee, strong tea, cola, chocolate, etc.) or consumed dragon fruit, mango, grapefruit (grapefruit) and other rutaceae fruits and beverages made from them within 48 hours before screening, or have consumed alcoholic food or beverages or have strenuous exercise (football, basketball, running, aerobics, swimming at the same intensity for more than 30 minutes), or have other factors that affect drug absorption, distribution, metabolism, excretion, etc.; 11) Those who have a habit of smoking (an average daily smoking of more than 5 cigarettes in the 3 months before screening) or drinking habits (an average of more than 28 units of alcohol per week in the 3 months before screening, 1 unit = 285mL of beer or 25mL of spirits with 40% alcohol or 75mL of wine); or those who cannot stop using any tobacco products during the trial; or those who cannot abstain from alcohol during the test; 12) History of drug abuse or drug abuse; 13) Those who have donated blood or had heavy bleeding (blood loss = 400mL) within 3 months before screening or have a blood donation plan during the trial; 14) Pregnant or lactating
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 ContactYingWang
Hangzhou Red Cross Hospital
Outcome results
None listed