Status:
COMPLETED
a Phase I PK Study in Healthy Male Subjects. 2 Groups of Healthy Male Subjects
Lead Sponsor:
Otsuka Beijing Research Institute
Collaborating Sponsors:
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Health Subjects
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
Tolvaptan oral administraction phase I PK clinical trial. Two groups of healthy male subjects. One group receives single dose of Tolvaptan. The other group receives multi dose of Tolvaptan.
Eligibility Criteria
Inclusion
- Healthy male volunteers.
- Aged 18 to 40 years old.
- Weight no less than 50kg and within the range of standard weight (body mass index between 19 and 24).
- Auxiliary examinations: blood routine and coagulation, urine routine, blood biochemistry (total protein, albumin, blood glucose, total bilirubin, AST (GOT), ALT (GPT), ALP, γ-GTP, LDH, CK (CPK), total cholesterol, triglycerides, urea nitrogen, creatinine, uric acid, Na, K, Cl, Mg, Ca, P), hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody, 12-lead electrocardiogram, 24-hour ambulatory electrocardiogram (Holter) examination, all items are normal.
- Signed the informed consent form.
Exclusion
- The patient has a history of heart, liver, kidney, digestive tract, metabolic, respiratory, blood, mental, nervous system and other disorders, and the doctor's judgment is not suitable.
- Hepatitis B virus, syphilis, hepatitis C virus, HIV infection.
- Patients with a history of clinically significant arrhythmias of various types, including rapid and slow types, such as atrioventricular block, sinus arrest, and supraventricular tachycardia, were assessed by the investigators.
- He has a history of postural hypotension (blood pressure drop ≥20/10mmHg when he changes from lying position to standing position, accompanied by dizziness and other symptoms), standing dizziness, collapse, fainting, and vertigo.
- Quiet for more than 3 minutes, sitting 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; Diastolic depression of 60mmHg or higher than 90mmHg.
- Various voiding disorders (frequent urination, or difficulty urinating, etc.).
- Have a family history of genetic diseases (including a history of genetically predisposed arrhythmias in relatives).
- A history, allergy or propensity to be allergic to drugs or any other substance.
- Smokers, alcoholics, or other drug addicts.
- Physical examination had clinically significant positive findings.
- People who have donated blood or been sampled as a subject within the last 3 months.
- People who have taken prophylactic or therapeutic drugs in the last 2 weeks.
- Otherwise, the clinical trial physician or the clinical trial physician determines that the safety of the trial is affected.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT07166796
Start Date
October 1 2006
End Date
January 31 2007
Last Update
September 10 2025
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