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

LG Life Sciences46 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

BEPO-ADRUG

BEPO-A (Bioreactor manufacturing process)

REPO-ADRUG

REPO-A (Roller bottle manufacturing process)

Eligibility

Sex: MALEMin age: 19 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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,

Data from ClinicalTrials.gov

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