Phase I Study Multi Dose of 7.5mg Tolvaptan in Health Male

Inclusion criteria

• Male, sign informed consent;
• When signing the informed consent, the age range is 18-40 years old (including the upper and lower limits);
• The body weight is not less than 50kg, and the body mass index is in the range of 19 ~ 24 (including the upper and lower limits);
• According to the results of medical history, serological examination (HIV antibody, HBsAg, HCV antibody and syphilis antibody), physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram, laboratory examination (blood routine, blood biochemistry, coagulation function and urine routine), etc., the subjects are certified as healthy.

Exclusion criteria

• Patients with a history of heart, liver, kidney, digestive tract, metabolic, respiratory, blood, mental, nervous system and other disorders, and doctors judge that they are not suitable.
• Patients with a history of various types of arrhythmias judged by the researchers to have clinical significance, including a history of familial genetic disease (a history of arrhythmias with a genetic tendency in relatives), and a history of rapid and slow arrhythmias, such as atrioventricular transmission Conduction block, sinus arrest, supraventricular tachycardia and so on.
• Have a history, allergy or tendency to drugs and any other substances.
• Known intolerance to components of the test drug, including lactose. For example, people with rare genetic galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
• Various voiding disorders (frequent urination, or difficulty urinating, etc.).
• People who smoke, drink or depend on other drugs.
• Blood donors had an equivalent amount of blood loss (>350 ml) during the 12 weeks prior to enrollment.
• Participated in any drug trials within 12 weeks prior to enrollment.
• People who have taken preventive or therapeutic drugs in the last 2 weeks.
• Consumed grapefruit or foods containing grapefruit in the week prior to administration.
• In the investigator's judgment, the subject's diet deviates significantly from the normal intake of protein, carbohydrates, and fats (for example, vegetarian or vegan).
• Have a history of postural hypotension (refers to a blood pressure drop of ≥20/10mmHg when the blood pressure changes from the lying position to the standing position, accompanied by dizziness and other symptoms), standing vertigo, collapse, syncopation, and vertigo.
• Quiet for more than 3 minutes, sitting resting pulse below 55 beats/min or more than 90 beats/min.
• Quiet for more than 3 minutes, sitting systolic blood pressure is lower than 100mmHg or higher than 140mmHg; Or diastolic depression of 60mmHg or more than 90mmHg.
• Clinically significant 12-lead electrocardiogram abnormalities.
• Clinically significant abnormalities in physical examination.
• Positive for any of the serological tests for HIV antibodies, HBsAg, HCV antibodies and syphilis antibodies.
• Other circumstances that the investigator determines may affect the subject's completion of the test.