Breast cancer
Conditions
Interventions
A:Twenty healthy individuals received HS-10352 tablets 6mg orally on a single empty stomach in D1, itraconazole capsules 200mg orally once daily immediately after breakfast in D5-D7, itraconazole caps
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be enrolled, subjects must meet all of the following criteria. 1) Age between 18 ~ 45 years (including cut-off values), both sexes. 2) Male subjects weighing = 50.0 kg and female subjects weighing = 45.0 kg with a body mass index (BMI) between 19 ~ 26 kg/m2, including cut-off values. 3) Subjects voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects meeting one or more of the following criteria will be excluded. 1) Those with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or abnormal physical examination, electrocardiogram, laboratory tests [liver function (ALT, AST, total bilirubin) >1 x ULN] of clinical significance (as judged by the clinical investigator). 2) Persons with any previous or current clinically serious disease of the circulatory, endocrine, neurological, digestive, respiratory, genitourinary, haematological, immunological, psychiatric and metabolic abnormalities or any other disease that can interfere with the test results. 3) Persons with any condition that increases the risk of elevated blood glucose, such as a previous history of primary diabetes, gestational diabetes, steroid-induced diabetes or other secondary diabetes, with acute or chronic pancreatitis. 4) The presence of factors that may increase the risk of QTc prolongation or arrhythmic events, such as previous history of organic heart disease, heart failure, myocardial infarction, angina pectoris, arrhythmia, torsional ventricular tachycardia, ventricular tachycardia, atrioventricular block, QT prolongation syndrome, 12-lead ECG with a Fridericia method-corrected QT interval (QTcF) = 470 msec (female)/450 msec (male) or any other clinically significant abnormality as determined by the clinician. 5) who have undergone surgical procedures within 4 weeks prior to the trial, or who are scheduled to undergo surgical procedures during the study period 6)those who have undergone surgery that would interfere with the absorption, distribution, metabolism, or excretion of the drug and who, in the judgment of the investigator, are unsuitable for enrollment 7) who have a history of dysphagia or any gastrointestinal disorder that would interfere with drug absorption and who, in the judgment of the investigator, are unsuitable for enrollment 8)a history of allergy to drugs, food or other substances 9)those who have taken any medication or health product (including herbal medicines) within 14 days prior to the trial 10) have used any drug that inhibits or induces hepatic metabolism of the drug within 30 days prior to the trial (e.g. CYP3A4 inducer carbamazepine, dexamethasone, rifampicin, phenytoin, phenobarbital, and onychomycin; CYP3A4 inhibitors itraconazole, ketoconazole, clarithromycin, telithromycin, lopinavir, ritonavir, etc.; CYP2C8 inducer rifampicin; CYP2C8 inhibitors (gefirozil, clopidogrel, deferasirox, teriflunomide, etc.). 11) Those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial 12) Those who have donated blood or lost a significant amount of blood (= 200 mL, excluding blood loss during menstruation in women), received a blood transfusion or used blood products within the 3 months prior to enrollment. 13) persons with special dietary requirements who are unable to comply with a uniform diet 14) those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day 15)smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to the trial or those who were unable to stop using any tobacco-based products during the trial 16) heavy drinkers or regular drinkers of alcohol in the 6 months prior to the trial, i.e. more than 14 units of alcohol per week (1 un
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration;Physical examination;Vital signs;Glucose metabolism-related indicators;12-lead ECG;Adverse events; | — |
Countries
China
Contacts
Public ContactGuoping Yang/Yuxia Xiang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed