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

March 17, 2016 updated by: LG Life Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BEPO-A
Single subcutaneous injection of BEPO-A 4000 IU (Bioreactor manufacturing process)
Drug: BEPO-A
BEPO-A (Bioreactor manufacturing process)
Active Comparator: REPO-A
Single subcutaneous injection of REPO-A 4000 IU (Roller bottle manufacturing process)
Drug: REPO-A
REPO-A (Roller bottle manufacturing process)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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,
1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,

Secondary Outcome Measures

Outcome Measure
Time Frame
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,
1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • LG-EPCL009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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