Status:
COMPLETED
Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to evaluate the effect of itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective...
Eligibility Criteria
Inclusion
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
Exclusion
- Allergic constitution;
- History of drug use, or drug abuse screening positive;
- Alcoholic or often drinkers;
- Left ventricular ejection fraction (LVEF) \<50% by echocardiography;
- A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
- Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
Key Trial Info
Start Date :
June 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04423601
Start Date
June 10 2020
End Date
February 2 2021
Last Update
October 18 2021
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120