| Trial ID: | L1168 |
| Source ID: | NCT01085552
|
| Associated Drug: |
Epoetin Beta
|
| Title: |
Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Failure|Anaemia
|
| Interventions: |
DRUG: Epoetin Beta
|
| Outcome Measures: |
Primary: To establish the pharmacokinetic parameters of Epoetin beta in healthy Japanese and Caucasian males., 21 Oct 2008|To compare the pharmacokinetic parameters AUCinf and Cmax in healthy Japanese and Caucasian males., 21 Oct 2008 | Secondary: To establish the pharmacodynamic parameters of a single dose of Epoetin beta in healthy Japanese and Caucasian males., 21 Oct 2008
|
| Sponsor/Collaborators: |
Sponsor: InCROM Europe Clinical Research
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
23
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose:
|
| Start Date: |
2007-11
|
| Completion Date: |
2008-10
|
| Results First Posted: |
|
| Last Update Posted: |
2010-03-12
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01085552
|
