Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1; Filgrastim 5 ㎍/kg | Experimental | 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. |
|
| Part 2; Filgrastim 10 ㎍/kg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leucostim® | Drug |
|
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of Filgrastim | PK parameter | 0~48 hr |
| AUC0-t of Filgrastim | PK parameter | 0~48 hr |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University College of Medicine | Seoul | Seodamun-gu | 03722 | South Korea |
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Neupogen® |
| Drug |
|
| 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 |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |