Evaluation of Pharmacokinetic/Pharmacodynamic Properties and Safety of Leucostim® Compared to Neupogen® in Healthy Adult Volunteers

Study Overview
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Brief Summary
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A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of Leucostim® and Neupogen® in Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Leucostim®
* Drug: Neupogen®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 - 45 years BMI 18.5 - 25.0 kg/m2 Value of ANC(absolute neutrophil count) had to be inside the normality range at the screening Exclusion Criteria: Subjects with a history or presence of clinically relevant hypersensitivity reaction to investigational drugs (G-CSF) or their ingredients/additives Subjects with a clinically relevant history of allergic reaction Subjects with a history of acute infectious diseases within 2 weeks prior to administration of investigational products At the investigator's discretion, subjects who is considered inappropriate to participate in the study due to any conditions including screening results

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1; Filgrastim 5 ㎍/kg<br>Neupogen®(Filgrastim) 5 ㎍/kg or Leucostim®(Filgrastim) 5 ㎍/kg will be administered subcutaneously on Period 1, Day 1. And wash out for 28 days or more. Leucostim®(Filgrastim) 5 ㎍/kg or Neupogen®(Filgrastim) 5 ㎍/kg will be administered subcutaneously on Period 2, Day 1. | Drug: Leucostim®<br> <br> * Other names: DA-3030;Drug: Neupogen®<br> <br> |
| Experimental: Part 2; Filgrastim 10 ㎍/kg<br>Neupogen®(Filgrastim) 10 ㎍/kg or Leucostim®(Filgrastim) 10 ㎍/kg will be administered subcutaneously on Period 1, Day 1. And wash out for 28 days or more. Leucostim®(Filgrastim) 10 ㎍/kg or Neupogen®(Filgrastim) 10 ㎍/kg will be administered subcutaneously on Period 2, Day 1. | Drug: Leucostim®<br> <br> * Other names: DA-3030;Drug: Neupogen®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Filgrastim | PK parameter | 0 48 hr | 
| Cmax of Filgrastim | PK parameter | 0 48 hr | 
| AUEC0-t of ANC(absolute neutrophil count) | PD parameter | 0 120 hr | 
| Emax of ANC(absolute neutrophil count) | PD parameter | 0 120 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of Filgrastim | PK parameter | 0 48 hr | 
| AUC0-t of Filgrastim | PK parameter | 0 48 hr | 
| CL/F of Filgrastim | PK parameter | 0 48 hr | 
| Vd/F of Filgrastim | PD parameter | 0 48 hr | 
| AUEC0-t of CD34+ cell count | PD parameter | 0 312 hr | 
| Emax of CD34+ cell count | PD parameter | 0 312 hr |