To investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of tolvaptan 15, 30 and 60 mg after single oral administration in healthy Korean male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
46
Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day
Seoul National University Hospital
Seoul, South Korea
PK parameters: AUC, Cmax, Tmax
Time frame: 1 day
PD parameters: 24 hour fluid balance
Time frame: 1 day
Safety: adverse event, body weight, physical examination, vital sign, ECG, clinical laboratory test
Time frame: 4 days
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