A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers
NCT ID: NCT05273775
Last Updated: 2022-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2022-04-29
2022-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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single arm
HRS5091 + probe drugs (Midazolam Maleate Tablets+Warfarin Sodium Tablets+ Omeprazole Enteric Capsules+ Digoxin Tablets+ Rosuvastatin Calcium) + Vitamin K1 Tablets
HRS5091 Tablets
HRS5091 Tablets once daily
Midazolam Maleate Tablets
Midazolam Maleate Tablets single dose
Warfarin Sodium Tablets
Warfarin Sodium Tablets single dose
Omeprazole Enteric Capsules
Omeprazole Enteric Capsules single dose
Vitamin K1 Tablets
Vitamin K1 Tablets once daily
Digoxin Tablets
Digoxin Tablets single dose
Rosuvastatin Calcium Tablets
Rosuvastatin Calcium Tablets single dose
Interventions
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HRS5091 Tablets
HRS5091 Tablets once daily
Midazolam Maleate Tablets
Midazolam Maleate Tablets single dose
Warfarin Sodium Tablets
Warfarin Sodium Tablets single dose
Omeprazole Enteric Capsules
Omeprazole Enteric Capsules single dose
Vitamin K1 Tablets
Vitamin K1 Tablets once daily
Digoxin Tablets
Digoxin Tablets single dose
Rosuvastatin Calcium Tablets
Rosuvastatin Calcium Tablets single dose
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
MALE
Yes
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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HRS5091-102
Identifier Type: -
Identifier Source: org_study_id