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Sponsored by: |
Hospira, Inc. |
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Information provided by: | Hospira, Inc. |
ClinicalTrials.gov Identifier: | NCT00938678 |
Compare pegylated granulocyte colony-stimulating factor (PEG-GCSF) pharmacokinetics (PK) and pharmacodynamics (PD) from Pegfilgrastim Hospira and Neulasta (R) following a single dose of 6 mg delivered by subcutaneous (SC) injection in healthy volunteers.
Condition | Intervention | Phase |
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Healthy |
Drug: Pegfilgrastim Hospira Drug: Neulasta (Amgen) |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase I, Randomized, Single Dose, Crossover Study Evaluating the Pharmacokinetics and Pharmacodynamics of Pegfilgrastim Hospira Compared to Neulasta (Amgen) Following Subcutaneous Administration to Healthy Volunteers |
Estimated Enrollment: | 70 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Treatment Group 1: Experimental |
Drug: Pegfilgrastim Hospira
Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
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Treatment Group 2: Active Comparator |
Drug: Neulasta (Amgen)
Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stuart Mair, MBChB, DRCOG, DCPSA | +44 (0) 1875 618 149 | stuart.mair@eur.crl.com |
United Kingdom, Lothian | |
Quotient Clinical Ltd | Recruiting |
Edinburgh, Lothian, United Kingdom, EH14 4AP | |
Principal Investigator: Stuart Mair, MBChB DRCOG DCPSA |
Responsible Party: | Hospira, Inc. ( Islah Ahmed, MD ) |
Study ID Numbers: | PEG-09-01, EudraCT Number 2009-101433-42 |
Study First Received: | July 10, 2009 |
Last Updated: | July 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00938678 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Healthy volunteers |
Healthy |