Evaluation of Pharmacokinetic/Pharmacodynamic Properties and Safety of Leucostim® Compared to Neupogen® in Healthy Adult Volunteers
Not Applicable
Completed
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0001861
- Lead Sponsor
- Dong-A ST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 56
Inclusion Criteria
1. Age 19 - 45 years
2. Body mass index(BMI) 18.5kg/m2 or greater but less than 25.0kg/m2
3. Value of ANC(absolute neutrophil count) had to be inside the normality range at the screening
Exclusion Criteria
1. Subjects with a history or presence of clinically relevant hypersensitivity reaction to investigational drugs (G-CSF) or their ingredients/additives
2. Subjects with a clinically relevant history of allergic reaction
3. Subjects with a history of acute infectious diseases within 2 weeks prior to administration of investigational products
4. At the investigator's discretion, subjects who is considered inappropriate to participate in the study due to any conditions including screening results
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK parameter : AUCinf, Cmax of Filgrastim;PD parameter : AUEC0-t, Emax of ANC(absolute neutrophil count)
- Secondary Outcome Measures
Name Time Method PK parameter : Tmax, AUC0-t, CL/F and Vd/F of Filgrastim;PD parameter : AUEC0-t, Emax of CD34+ cell count