None listed
Conditions
Interventions
Intervention1: Neulasta (EU)
Neulasta (US): 6mg/0.6ml, Single Dose, Subcutaneous
Control Intervention1: Pegfilgrastim from zydus: 6mg/0.6ml, Single Dose, Subcutaneous
Sponsors
Cadila Healthcare limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated written informed consent prior to any study specific procedures 2. Willing and able to comply with the study procedures, restrictions and requirements 3. At least (>=) 18 years of age and no more than ( 4. Body mass index (BMI) >=19.0 and 5. In general good health as determined by an experienced physician based on a comprehensive medical history and physical examination. Minor abnormalities in laboratory testing are allowable if not contraindicated by this protocol, and if in the estimation of the Investigator, pose no additional risk to participation nor interference with study procedures
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Escherichia coli derived proteinsâ?? pegfilgrastimâ?? filgrastim or any other component of Zydus pegfilgrastim or Neulasta® 2. Hereditary problems with fructose intolerance and/or sorbitol 3. Any prior exposure to any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or pegfilgrastim; or prior immunoglobulin preparations within the past six months 4. Positive standard drug as well as alcohol screen 5. Blood donation in the past 3 months, or bone marrow or stem cell donor in the past 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) Area under the curve from time zero (predose) to the time of last quantifiable concentration using linear-up/log-down trapezoidal summation (AUC(0-last)Timepoint: Day 1 (predose) to Day 6 (120 hours postdose) and thereafter postdose samples will be collected on outpatient visits on Days 8, 10, 12, 15, 18 and 21 for each treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Area under the curve from time zero (predose) extrapolated to infinity using linear-up/log-down trapezoidal summation (AUC(0-inf)) â?¢Time to maximum concentration (tmax) â?¢Apparent half-life (t1/2)Timepoint: Day 1 (predose) to Day 6 (120 hours postdose) and thereafter postdose samples will be collected on outpatient visits on Days 8, 10, 12, 15, 18 and 21 for each treatment period | — |
Countries
India
Contacts
Public ContactDr Charu Gautam
Cliantha Research Limited
Outcome results
None listed