Study to compare two formulations of pegfilgrastim in healthy males

Not Applicable

Registration Number: CTRI/2014/08/004815

Lead Sponsor: Cadila Healthcare limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 90

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 (<=) 45 years of age at the time of signing informed consent

4.Body mass index (BMI) >=19.0 and <=25.0 kg/m2 (inclusive) and a body weight of 50 to 100 kg (inclusive)

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

1.Known hypersensitivity to Escherichia coli derived proteinsâ?? pegfilgrastimâ?? filgrastim or any other component of Zydus pegfilgrastim or NeulastaÂ®

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

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum observed concentration (Cmax) <br/ ><br>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 <br/ ><br>outpatient visits on Days 8, 10, 12, 15, 18 and 21 for each treatment period

Secondary Outcome Measures

Name	Time	Method
â?¢Area under the curve from time zero (predose) extrapolated to infinity using linear-up/log-down trapezoidal summation (AUC(0-inf)) <br/ ><br>â?¢Time to maximum concentration (tmax) <br/ ><br>â?¢Apparent half-life (t1/2)Timepoint: Day 1 (predose) to Day 6 (120 hours postdose) and thereafter postdose samples will be collected on <br/ ><br>outpatient visits on Days 8, 10, 12, 15, 18 and 21 for each treatment period