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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02426151

Enrollment

Registered

2015-04-24

Start date

2015-04-30

Completion date

2015-09-30

Last updated

2016-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGBEPO-A

BEPO-A (Bioreactor manufacturing process)

DRUGREPO-A

REPO-A (Roller bottle manufacturing process)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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,

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026