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

NCT01014416 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2010-03-11

No results posted yet for this study

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

DRUG

Tolvaptan 15mg or 30mg or 60mg or Placebo

Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day

Sponsors & Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, MD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01014416 on ClinicalTrials.gov