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To Investigate the Pharmacokinetics of EPORON® and EPREX® After Subcutaneous Administration in Healthy Male Volunteers

NCT02580006 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-10-20

No results posted yet for this study

Summary

This Phase I study is to compare pharmacokinetics, safety and pharmacodynamics of EPORON and EPREX after single subcutaneous administration.

Conditions

  • Healthy

Interventions

DRUG

EPORON

single dose administration subcutaneously

DRUG

EPREX

single dose administration subcutaneously

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-sang Yu, MD, Ph.D · Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital

  • In-jin Jang, MD, Ph.D · Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital

  • Hyung-gi Lee, MD, Ph.D · Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital

  • Ju-yeon Cho, Ph.D · Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital

  • Seung-hwan Lee, MD, Ph.D · Seoul National University Hospital Clinical Trials Center / Clinical Pharmacology of Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-01-31
Completion
2016-03-31

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 NCT02580006 on ClinicalTrials.gov