Phase I Study Multi Dose of 7.5mg Tolvaptan in Health Male
- Registration Number
- NCT07166887
- Lead Sponsor
- Otsuka Beijing Research Institute
- Brief Summary
pharmacokinetics, pharmacological effects and safety of multi dose of 7.5mg Tolvaptan tablet in healthy male subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 7.5mg Tolvaptan multi dosing group Tolvaptan -
- Primary Outcome Measures
Name Time Method Tolvaptan Pharmacokinetic On Day 1: 0.5 hour before the first dose - the Day 9th pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, day 24 (only on Day 2 and Day 10th morning), 36 ( on Day 2 and Day 10th everning) and 48 hours - Day 4th to 8th day pre-dose apparent volume of distribution (Vd/F)
- Secondary Outcome Measures
Name Time Method