NCT01085552

Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects

A Phase I Single Centre Open Label Trial to Investigate the Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta (NeoRecormon®) in Healthy Japanese and Caucasian Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: InCROM Europe Clinical Research · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A study to see how a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese compares with a single subcutaneous dose of Epoetin beta (NeoRecormon®) in Caucasian Male subjects. Each subject received a single subcutaneous dose of 50IU/kg of NeoRecormon Multidose solution on Day 1.

Detailed description

Ethnic comparison studies are becoming common research requirements in order to identify differences in response to drugs in various ethnic populations. This study will investigate the pharmacokinetic parameters and pharmacodynamic response in healthy Caucasian and Japanese male subjects after a single subcutaneous administration of 50IU/kg Epoetin beta This is a Phase I single centre, open label trial to investigate the bioequivalence of a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese and Caucasian Male subjects. The primary objectives are 1) to establish the pharmacokinetic parameters of Epoetin beta in healthy Japanese and Caucasian males, and 2) to compare the pharmacokinetic parameters AUCinf and Cmax in healthy Japanese and Caucasian males. The secondary objective is to establish the pharmacodynamic parameters of a single dose of Epoetin beta in healthy Japanese and Caucasian males. Subjects will receive a single subcutaneous administration of 50IU/kg on one occasion only. The planned study duration is approximately 1 month.

Conditions

• Chronic Kidney Failure
• Anaemia

Interventions

Type	Name	Description
DRUG	Epoetin Beta	Epoetin Beta. A single subcutaneous dose of 50IU/kg on Day 1. The body weight recording on day -1 will be used to calculate the dosage

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2010-03-12
• Last updated: 2010-03-12