Pharmacokinetics/Pharmacodynamics (PK/PD) Characteristics of Tolvaptan Tablet in Korean Healthy Male
Summary
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 Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic S
Conditions
Healthy
Intervention
Tolvaptan 15mg or 30mg or 60mg or Placebo
Location
Seoul National University Hospital
Seoul
Korea, Republic of
Status
Completed
Source
Korea Otsuka Pharmaceutical Co.,Ltd.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01014416
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Clinical Trials
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PubMed Articles
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Tolvaptan in Autosomal Dominant Polycystic Kidney Disease.
To the Editor: In the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcome (TEMPO) 3:4 trial, Torres et al. (Dec. 20 issue)(1) found that tolvapt...
Tolvaptan in Autosomal Dominant Polycystic Kidney Disease.
To the Editor: In the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcome (TEMPO) 3:4 trial, Torres et al. (Dec. 20 issue)(1) found that tolvapt...
Tolvaptan in Autosomal Dominant Polycystic Kidney Disease.
To the Editor: In the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcome (TEMPO) 3:4 trial, Torres et al. (Dec. 20 issue)(1) found that tolvapt...
