Status:
COMPLETED
A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Chronic Hepatitis B
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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, dig...
Eligibility Criteria
Inclusion
- The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent;
- Healthy subjects aged 18\~50 (including 18 and 50 years old);
- 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));
- Give informed consent not to have a family plan for six months after the last dose, and agree to take effective contraception.
Exclusion
- Has the medicine or food allergy history, or is the allergic constitution person;
- Inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors affecting drug use and absorption;
- QTCF \> 450 ms in 12-lead ECG examination or other abnormal conditions judged by the researchers to have clinical significance;
- Hepatitis B surface Antigen (HBSAG), Hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, syphilis antibody test positive;
- 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;
- 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;
- Having a history of drug abuse, drug dependence (consultation) or positive urine drug abuse screening before drug administration;
- Anyone who has undergone any surgery within 6 months prior to screening;
- 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.
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05273775
Start Date
April 29 2022
End Date
June 23 2022
Last Update
December 23 2022
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260