PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects.
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ClinicalTrials.gov Identifier: NCT01664221 |
Recruitment Status
: Unknown
Verified August 2012 by Azidus Brasil.
Recruitment status was: Not yet recruiting
First Posted
: August 14, 2012
Last Update Posted
: August 14, 2012
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Sponsor:
Azidus Brasil
Information provided by (Responsible Party):
Azidus Brasil
Tracking Information | |||
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First Submitted Date ICMJE | July 25, 2012 | ||
First Posted Date ICMJE | August 14, 2012 | ||
Last Update Posted Date | August 14, 2012 | ||
Study Start Date ICMJE | February 2013 | ||
Estimated Primary Completion Date | October 2013 (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 | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects. | ||
Official Title ICMJE | Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Eritromax (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study. | ||
Brief Summary | The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects following administration of multiple intravenous dose. The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the test drug Eritromax® marketed by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy subjects. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 1 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Healthy | ||
Intervention ICMJE | Drug: Epoetin Alfa
Intravenous administration of the drug, test or comparator, for 4 weeks, 3 times a week (monday, wednesday and friday).
Other Names:
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Study Arms |
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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 | Unknown status | ||
Estimated Enrollment ICMJE |
80 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date | October 2013 | ||
Estimated Primary Completion Date | October 2013 (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 55 Years (Adult) | ||
Accepts Healthy Volunteers | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Brazil | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01664221 | ||
Other Study ID Numbers ICMJE | EPOBLA0412IV-I Version 1 09/04/2012 ( Other Identifier: LAL Clinica ) |
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Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Azidus Brasil | ||
Study Sponsor ICMJE | Azidus Brasil | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Azidus Brasil | ||
Verification Date | August 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |