Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects
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ClinicalTrials.gov Identifier: NCT01085552 |
Recruitment Status
:
Completed
First Posted
: March 12, 2010
Last Update Posted
: March 12, 2010
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Tracking Information | ||||
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First Submitted Date ICMJE | March 11, 2010 | |||
First Posted Date ICMJE | March 12, 2010 | |||
Last Update Posted Date | March 12, 2010 | |||
Study Start Date ICMJE | November 2007 | |||
Actual Primary Completion Date | October 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
To establish the pharmacodynamic parameters of a single dose of Epoetin beta in healthy Japanese and Caucasian males. [ Time Frame: 21 Oct 2008 ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects | |||
Official Title ICMJE | 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 | |||
Brief 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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) |
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Condition ICMJE |
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Intervention ICMJE | 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 |
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Study Arms | 1
Group A consists of 11 Caucasian male subjects Group B consists of 12 Japanese male subjects
Intervention: Drug: Epoetin Beta |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
23 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | October 2008 | |||
Actual Primary Completion Date | October 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years to 40 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01085552 | |||
Other Study ID Numbers ICMJE | EICE07060 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Dr Daryl Bendel, InCROM Europe Clinical Research | |||
Study Sponsor ICMJE | InCROM Europe Clinical Research | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | InCROM Europe Clinical Research | |||
Verification Date | March 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |