Patients with fluid retention caused by hyponatremia and heart failure
Conditions
Interventions
A:TR
B:RT
C:TR
D:RT
Sponsors
Clinical Trial Ethics Committee of the Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must give informed consent to this study before the experiment, and voluntarily sign a written informed consent form; 2) Gender: male and female healthy subjects, and the selected subjects should have an appropriate gender ratio; 3) Age: healthy subjects over 18 years old (including boundary values); 4) Body weight: male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, body mass refers to The number [BMI=weight (kg)/height 2 (m2)] is within the range of 19.0-26.0kg/m2 (including the boundary value); 5) The subject can communicate well with the researcher and can complete the research in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: 1) Those who participated in other clinical trials and used study drugs within 3 months before the trial; 2) During the screening period physical examination, vital sign measurement, electrocardiogram examination, chest CT examination, laboratory examination (blood routine, urine routine, blood biochemistry, blood coagulation function, etc.) the investigator judges that the abnormality has clinical significance; or the physical examination has jaundice; 3) Those who have a history of cardiovascular, liver, kidney, endocrine, metabolism, digestive tract, blood system, respiratory system, infection, malignant tumor, mental abnormality, etc. that the researcher judges to be clinically significant, or have the above-mentioned diseases; or People who have difficulty urinating (such as enlarged prostate or urinary disorders); or those who cannot perceive or respond normally to thirst; 4) Those who have undergone major surgery within 6 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion (except for appendicitis surgery); 5) Those who have used long-acting estrogen or progesterone injections or implants within 6 months before the test; or those who have used short-acting contraceptives within 30 days before the test; 6) Platan has interacting drugs (such as CYP3A inhibitors ketoconazole, clarithromycin, itraconazole, telithromycin, saquinavir, nifinavir, ritonavir, nefazol, erythromycin Vitamins, fluconazole, aprepitant, diltiazem, verapamil, etc., P glycoprotein inhibitors and CYP3A inducers such as rifampicin, rifabutin, rifapentine, barbiturates, phenytoin , Carbamazepine, Hypericum perforatum, etc.); 7) Those who have used any prescription drugs, non-prescription drugs, Chinese herbal medicines, or health care products within 14 days before the test; 8) Those who had a positive drug test before the first drug administration or a history of drug abuse (such as morphine, methamphetamine, ketamine, dimethyldioxyamphetamine, tetrahydrocannabinol acid, etc.) within 1 year before the test 9) Those who are allergic to tolvaptan and its related compounds and any ingredients in excipients, or are allergic to two or more drugs (or food); 10) Donated blood/blood loss >= 400mL within 3 months before the test, or plan to donate blood or blood components during the study period or within 3 months after the end of the study; 11) Those who smoked more than 5 cigarettes per day in the 3 months before screening, and those who could not accept smoking bans after being selected to the whole trial period; 12) Those who have taken any alcohol-containing products within 24 hours before the first administration of the study, or whose alcohol breath test result is greater than 0.0mg/100mL, or drink more than 14 standard units per week (1 standard unit contains 14g alcohol, such as 360mL beer or 45mL 40% spirits or 150mL wine); or selected People who are prohibited from drinking alcohol cannot be accepted during the whole trial period; 13) Those who have consumed excessive amounts of tea, coffee or caffeine-containing beverages (more than 8 cups a day, 1 cup=200mL) for a long period of time (within 3 months before screening); or consumed any caffeine-containing beverages within 48 hours before enrollment Food or beverages (such as coffee, strong tea, chocolate, etc.); 14) Those who have consumed any beverages or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed