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

NCT ID: NCT02426151

Last Updated: 2016-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-09-30

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BEPO-A

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

Group Type: EXPERIMENTAL

BEPO-A

Intervention Type: DRUG

BEPO-A (Bioreactor manufacturing process)

REPO-A

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

Group Type: ACTIVE_COMPARATOR

REPO-A

Intervention Type: DRUG

REPO-A (Roller bottle manufacturing process)

Interventions

BEPO-A

BEPO-A (Bioreactor manufacturing process)

Intervention Type: DRUG

REPO-A

REPO-A (Roller bottle manufacturing process)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LG-EPCL009

Identifier Type: -

Identifier Source: org_study_id