NCT01014416

Pharmacokinetics/Pharmacodynamics (PK/PD) Characteristics of Tolvaptan Tablet in Korean Healthy Male

A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalation Study to Investigate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Tolvaptan in Healthy Korean Male Subjects Bipolar Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tolvaptan 15mg or 30mg or 60mg or Placebo	Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-11-17
• Last updated: 2010-03-11

Locations

1 site across 1 country: South Korea