NCT02426151

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 19 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	BEPO-A	BEPO-A (Bioreactor manufacturing process)
DRUG	REPO-A	REPO-A (Roller bottle manufacturing process)

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-05-01
• Completion: 2015-09-01
• First posted: 2015-04-24
• Last updated: 2016-03-18