Status:
COMPLETED
Phase I Study Multi Dose of 7.5mg Tolvaptan in Health Male
Lead Sponsor:
Otsuka Beijing Research Institute
Conditions:
Healthy Subjects
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
pharmacokinetics, pharmacological effects and safety of multi dose of 7.5mg Tolvaptan tablet in healthy male subjects
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 7 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07166887
Start Date
June 7 2011
End Date
July 27 2011
Last Update
September 10 2025
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