Healthy
Conditions
Brief summary
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
Interventions
DRUGLeucostim®
DRUGNeupogen®
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf of Filgrastim | 0~48 hr | PK parameter |
| Cmax of Filgrastim | 0~48 hr | PK parameter |
| AUEC0-t of ANC(absolute neutrophil count) | 0~120 hr | PD parameter |
| Emax of ANC(absolute neutrophil count) | 0~120 hr | PD parameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUEC0-t of CD34+ cell count | 0~312 hr | PD parameter |
| Tmax of Filgrastim | 0~48 hr | PK parameter |
| Emax of CD34+ cell count | 0~312 hr | PD parameter |
| AUC0-t of Filgrastim | 0~48 hr | PK parameter |
| CL/F of Filgrastim | 0~48 hr | PK parameter |
| Vd/F of Filgrastim | 0~48 hr | PD parameter |
Countries
South Korea
Outcome results
None listed