52.5% male and Sex distribution: Sex distribution: Sex distribution: 47.5% female 54% males and 59% male and 54% male and 46% female 41% female. 46% female Dose 10 µg/kg 5 µg/kg 2.5 or 5 µg/kg 1 µg/kg Frequency of Daily SC injections Single IV injection Daily SC Single SC injection dosing for seven days injections for 7 days. Objectives Primary: Evaluate Primary: Evaluate Primary: Evaluate Primary: Evaluate PK bioequivalence PK bioequivalence PD equivalence. PD equivalence. Secondary: Secondary: Secondary: Secondary: Safety, Safety, local Compare PD, Compare PD and local tolerance, tolerance, PK safety, local Safety PK. tolerance. Main PK Confirmatory Confirmatory Descriptive Descriptive results analysis analyses analyses analyses demonstrate that demonstrate that demonstrate that demonstrate that at 10µg/kg/day, EP2006 is the 90% EP2006 is EP2006 and bioequivalent to confidence bioequivalent to Neupogen are Neupogen for both intervals for all Neupogen for bioequivalent AUC and Cmax. single-dose and both AUC and within the The 90% multiple-dose Cmax. The 90% predefined confidence AUCs were confidence accepted criteria intervals were included within intervals were of 80-125% for within the the conventional within the the 90% defined accepted 80-125% confidence range of 80-125% criterion, as was acceptance range intervals of AUC for AUC and the 90% CI for of 80-125%. and 75-133% for Cmax. Cmax after a confidence single dose of 5 intervals of Cmax, µg/kg. The CI for both after the first Cmax after a dose and at steady single dose of 2.5 state. µg/kg was within the boundaries of 75-133%. At 2.5 µg/kg and at 5 µg/kg (multiple dose) the CIs for Cmax were contained within the extended boundaries Evaluator’s overall conclusions on pharmacokinetics Pharmacokinetic equivalence was demonstrated between EP2006 and Neupogen by the Phase I studies.
52.5% male and 47.5% female Sex distribution: 54% males and 46% female Sex distribution: 59% male and 41% female. Sex distribution: 54% male and 46% female Dose 10 µg/kg 5 µg/kg 2.5 or 5 µg/kg 1 µg/kg Frequency of dosing Daily SC injections for seven days Single IV injection Daily SC injections for 7 days. Single SC injection Objectives Primary: Evaluate PK bioequivalence Secondary: Compare PD, safety, local tolerance. Primary: Evaluate PK bioequivalence Secondary: Compare PD and Safety Primary: Evaluate PD equivalence. Secondary: Safety, local tolerance, PK Primary: Evaluate PD equivalence. Secondary: Safety, local tolerance, PK. Main PK results Confirmatory analysis demonstrate that at 10µg/kg/day, EP2006 and Neupogen are bioequivalent within the predefined accepted criteria of 80-125% for the 90% confidence intervals of AUC and 75-133% confidence intervals of Cmax, both after the first dose and at steady state. Confirmatory analyses demonstrate that EP2006 is bioequivalent to Neupogen for both AUC and Cmax. The 90% confidence intervals were within the accepted range of 80-125% for AUC and for Cmax. Descriptive analyses demonstrate that the 90% confidence intervals for all single-dose and multiple-dose AUCs were included within the conventional 80-125% criterion, as was the 90% CI for Cmax after a single dose of 5 µg/kg. The CI for Cmax after a single dose of 2.5 µg/kg was within the boundaries of 75-133%. At 2.5 µg/kg and at 5 µg/kg (multiple dose) the CIs for Cmax were contained within the extended boundaries Descriptive analyses demonstrate that EP2006 is bioequivalent to Neupogen for both AUC and Cmax. The 90% confidence intervals were within the acceptance range of 80-125%. Evaluator’s overall conclusions on pharmacokinetics Pharmacokinetic equivalence was demonstrated between EP2006 and Neupogen by the Phase I studies. defined
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