Skip to main content
OpenTrials
Completed

NCT Number: NCT02426151

Bioequivalence of a Single Subcutaneous Dose of BEPO and REPO in Healthy Male Subjects

To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male Subjects

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

19 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

To Compare Pharmacokinetic and Pharmacodynamic Profiles of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Agree to all the purposes of the study by signing and dating the Informed Consent;
  • Male, aged between 19 and 40 years, clinically healthy;
  • BMI between 19 and 28;
  • 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP < 85 mmHg

Exclusion criteria

  • Hemoglobin <13 g / dL
  • Ferritin <20 ng/mL or TIBC > 360 ug/ dL
  • Vitamin B12 < 200 pg/mL or floate < 4 ng/mL
  • %reticulpcyte > 3%
  • platelet < 100,000/ul or > 400,000/ul
  • GFR < 60mL/min/1.73m2
  • Going to or during treatment of the tumor
  • Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation
  • Clinical history of autoimmune or hereditary anemia
  • A Positive reaction in the nicotine tests
  • Principal Investigator of the study criteria.

Treatment and study plan

BEPO-A

Drug

BEPO-A (Bioreactor manufacturing process)

REPO-A

Drug

REPO-A (Roller bottle manufacturing process)

Primary outcomes

  1. Cmax and AUClast

    Time frame: 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,

Secondary outcomes

  1. AUCinf, Tmax, t1/2β, CL/F, MRTinf (mean residence time) of Erythropoietin

    Time frame: 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

A Randomized, Open Label, Single-dose 2x2 Crossover Study to Compare Pharmacokinetic, Pharmacodynamic Profiles, and Tolerability of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 24, 2015
Registry last updated
Mar 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.