Chronic Hepatitis B
Conditions
Brief summary
This is a drug-drug interaction study conducted in healthy volunteers to evaluate the effect of HRS5091 on CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP and OATP1B1, using midazolam, s-warfarin, omeprazole, digoxin and rosuvastatin as probe drugs.
Interventions
DRUGHRS5091 Tablets
HRS5091 Tablets once daily
Midazolam Maleate Tablets single dose
Warfarin Sodium Tablets single dose
Omeprazole Enteric Capsules single dose
Vitamin K1 Tablets once daily
DRUGDigoxin Tablets
Digoxin Tablets single dose
Rosuvastatin Calcium Tablets single dose
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Single-center, single arm, open-label, fixed sequence, self-control
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent; 2. Healthy subjects aged 18\ 50 (including 18 and 50 years old); 3. Body weight ≥ 50 kg, body mass index (BMI) within the range of 19 \ 26 kg /m2 (including 19 and 26 kg/m2) (BMI= weight (kg)/height2 (m2)); 4. Give informed consent not to have a family plan for six months after the last dose, and agree to take effective contraception.
Exclusion criteria
1. Has the medicine or food allergy history, or is the allergic constitution person; 2. Inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors affecting drug use and absorption; 3. QTCF \> 450 ms in 12-lead ECG examination or other abnormal conditions judged by the researchers to have clinical significance; 4. Hepatitis B surface Antigen (HBSAG), Hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, syphilis antibody test positive; 5. Those who smoked more than 5 cigarettes per day within 3 months before screening and could not stop using any tobacco products during the trial period; 6. Regular drinkers who had consumed more than 14 units of alcohol per week (1 unit = 285 ml of beer, 25 ml of spirits, or 100 ml of wine) during the six months prior to screening and could not stop using any alcoholic product during the trial; positive Breath test for alcohol; 7. Having a history of drug abuse, drug dependence (consultation) or positive urine drug abuse screening before drug administration; 8. Anyone who has undergone any surgery within 6 months prior to screening; 9. Clinical trial participants who have participated in any drug or medical device within 3 months prior to screening (subject to the intervention of the experimental drug or medical device);10.Blood donation (or blood loss) within 3 months before screening and the amount of blood donation (or blood loss)≥400 ml, or receiving blood transfusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091 | Days 1-27 |
| AUC0-t，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091 | Days 1-27 |
| AUC0-∞，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091 | Days 1-27 |
Secondary
| Measure | Time frame |
|---|---|
| Vz/F，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091 | Days 1-27 |
| Tmax，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091 | Days 1-27 |
| Number of subjects with adverse events and severity of adverse events | Up to 56 days |
| t1/2，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091 | Days 1-27 |
| CL/F，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091 | Days 1-27 |
Countries
China
Outcome results
None listed