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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BEPO-A; Drug: REPO-A

• Registration Number: NCT02426151
• Lead Sponsor: LG Life Sciences

Brief Summary

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

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 Timeline

• Status Verified: 2015-04
• Study Start: 2015-04
• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-24
• Primary Completion: 2015-05
• Study Completion: 2015-09
• Last Update Submitted: 2016-03-17
• Last Update Posted: 2016-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BEPO-A	BEPO-A	Single subcutaneous injection of BEPO-A 4000 IU (Bioreactor manufacturing process)
REPO-A	REPO-A	Single subcutaneous injection of REPO-A 4000 IU (Roller bottle manufacturing process)

Primary Outcome Measures

Name	Time	Method
Cmax and AUClast	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

Name	Time	Method
AUCinf, Tmax, t1/2β, CL/F, MRTinf (mean residence time) of Erythropoietin	1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,