Clinical trial
Single Center, Randomized, Double-blind, 3-Period, 3-Treatments, 3-Way Crossover Pharmacokinetics (PK)/Pharmacodynamics (PD) Trial to Assess PK, PD,Safety and Tolerability of MYL-1401H After Single Subcutaneous Injection at One Dose Level (2 mg) Comparing to an EU and US Marketed Drug Product (Neulasta®) in Healthy Volunteers.
NCT02479646 is registered in ClinicalTrials.gov with Mylan Inc. as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- Single Center, Randomized, Double-blind, 3-Period, 3-Treatments, 3-Way Crossover Pharmacokinetics (PK)/Pharmacodynamics (PD) Trial to Assess PK, PD,Safety and Tolerability of MYL-1401H After Single Subcutaneous Injection at One Dose Level (2 mg) Comparing to an EU and US Marketed Drug Product (Neulasta®) in Healthy Volunteers.
- Lead sponsor
- Mylan Inc.
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- September 30, 2014
- Completion date
- June 30, 2015
- Enrollment
- 218 (actual)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
healthy volunteers