Breast cancer
Conditions
Interventions
Fasting-postprandial sequence:Take NTQ1062 tablets orally
Postprandial-fasting sequence:Take NTQ1062 tablets orally
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Chinese volunteers aged 18 to 45 years (inclusive of the critical values), both male and female; 2.Male volunteers should have a body weight of >= 50.0 kg, and female volunteers should have a body weight of>=45.0 kg. The body mass index (BMI) should be between 19.0 and 26.0 kg/m^2, inclusive of the critical values. 3.The subjects voluntarily signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Those with a history of or currently suffering from any clinically severe diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry, metabolic abnormalities, or any other diseases that may interfere with the trial results. 2.Those with a history of allergies to drugs, food, or other substances, or allergies to any active or inactive ingredients of this product, or a history of allergic diseases (such as skin rashes, etc.) that the researcher considers to be clinically significant at present. 3.Those who had symptoms such as nausea, vomiting, diarrhea within 14 days before the first administration, and the researcher deems it inappropriate for them to participate in the trial. 4.Those who had symptoms such as oral ulcers within 14 days before the first administration, and the researcher deems it inappropriate for them to participate in the trial. 5.Those with a history of diabetes. 6.Those who have undergone surgical operations within 4 weeks before the trial or plan to undergo surgical operations during the trial. 7.Those who have taken any drugs or health products (including Chinese herbal medicines) within 14 days before the trial. 8.Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before the trial (such as: inducers—barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors—SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines). 9.Those who have used drugs that may interact with the trial drug within 30 days before the trial, such as CYP3A inhibitors (e.g., clarithromycin), CYP3A inducers (e.g., rifampicin), CYP3A substrates (e.g., alfentanil), etc. 10.Those who have had chronic or active digestive tract diseases such as esophageal diseases, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or digestive tract surgery within 3 years before the trial, and the researcher considers them to be clinically significant at present. 11.Those who have participated in any clinical trial and taken any clinical trial drugs within 3 months before the trial. 12.Those who have been vaccinated within 4 weeks before the trial or plan to be vaccinated during the trial. 13.Those who have donated blood or lost a large amount of blood (=200 mL, excluding blood loss during female menstruation), received blood transfusion, or used blood products within 3 months before enrollment. 14.Pregnant or lactating women, and volunteers (or their partners) who cannot adopt one or more non-drug contraceptive measures during the trial. 15.Those who have special dietary requirements and cannot comply with the unified diet. 16.Those who drink excessive amounts of tea, coffee, and/or caffeinated beverages every day (more than 8 cups, 1 cup = 250 mL). 17.Chain smokers, those who smoked more than 5 cigarettes per day within 3 months before the trial, or those who cannot stop using any tobacco products during the trial. 18.Alcoholics or those who drink regularly within 6 months before the trial, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine), or those who cannot stop using any alcohol-containing products during the trial. 19.Those with a positive alcohol breath test (> 0 mg/100 mL). 20.D
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed