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Pharmacokinetic, Pharmacodynamic and Safety Evaluation After Single Oral Administration of KRN1493

NCT00952094 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2009-08-04

No results posted yet for this study

Summary

Randomized, open, single ascending dose, parallel study to evaluate the pharmacokinetics, pharmacodynamics and safety of KRN1493 after single oral administration in healthy Korean male volunteers.

Conditions

  • Healthy

Interventions

DRUG

KRN1493

KRN1493 25mg tablet 2,3 or 4 tablets single oral administration

Sponsors & Collaborators

  • Jeil-Kirin Pharmaceutical Inc.

    collaborator INDUSTRY

  • Kyowa Hakko Kirin Pharma, Inc.

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Kyung-Sang Yu, M.D., Ph.D. · Seoul National University College of Medicine and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-01-31
Completion
2009-06-30

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 NCT00952094 on ClinicalTrials.gov