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

LG Life Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: REPO-A; Drug: BEPO-A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02426151

LG-EPCL009

Details and patient eligibility

About

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

Full description

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

Enrollment: 46 patients

Sex: Male

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

46 participants in 2 patient groups

BEPO-A

Experimental group

Description:

Single subcutaneous injection of BEPO-A 4000 IU (Bioreactor manufacturing process)

Treatment:

Drug: BEPO-A

REPO-A

Active Comparator group

Description:

Single subcutaneous injection of REPO-A 4000 IU (Roller bottle manufacturing process)

Treatment:

Drug: REPO-A