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This study evaluated the effect of the drug Itraconazole on the pharmacokinetics (how the body absorbs and processes it) of the drug SHR6390 in healthy volunteers. Healthy male and female volunteers aged 18-45 were eligible. The study was conducted in Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions; 2. Ability to complete the study as required by the protocol; 3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent; 4. 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 Criteria: 1. Allergic constitution; 2. History of drug use, or drug abuse screening positive; 3. Alcoholic or often drinkers; 4. Left ventricular ejection fraction (LVEF) \<50% by echocardiography; 5. 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. 6. 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.