A Comparative Evaluation of Pharmacokinetics and Immunogenicity.

An Open label, randomized, single-dose, two sequences, two-period crossover comparative Pharmacokinetic, immunogenicity and safety study under fasting conditions. Duration of the clinical phase will be approximately 51 days starting from admission of period I until giving the last sample in period II. A washout period of at least 34 days will be kept between dosing day in period I and dosing day period II. Approximate volume of blood loss in the study will be 309 mL for both male and female's subjects. A total of Twenty-two (22) blood samples for PK parameters will be collected in SST tubes in each study period. Blood samples (5.0 mL) will be collected at pre-dose (00.00 hr) in the morning of dosing day (day 1) within 01.00 hour prior to dosing and at 00.33, 00.50, 00.75, 01.00, 02.00, 04.00, 06.00, 08.00, 10.00, 12.00,14.00, 16.00, 20.00, 24.00 (day 2), 36.00, 48.00 (day 3), 72.00 (day 4), 120.00 (day 6), 192.00 (day 9), 264.00 (day 12), 336.00 (day 15) hours post-dose during each study period. Immunogenicity samples for ADA detection (anti-PEG- antibody) and Nab (Neutralizing antibodies) will be collected at pre- dose, and on day 15 (4.0 mL for each sampling time/ test) during each study period, into SST tubes. Summary Statistics will be calculated for Pegfilgrastim pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf, Tmax, t12, Kel and AUC Extrapolated. Statistical tests like ANOVA, least square means for test and reference products, Two One- Sided Tests for 90% confidence interval limits and power will be calculated for In-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf Geometric least square means of test and reference products, it's ratio, 90% confidence interval for geometric least square means ratio and intra-subject variability will be calculated for pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Pegfilgrastim. Dose normalization for Cmax, AUC0-t and AUC0-inf will be done considering the actual administered dose for each subject (based on the difference in PFS/OBI/AI weight before and after dosing). This is an additional PK analysis dataset.