Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01549301

Enrollment

128

Registered

2012-03-09

Start date

2012-08-31

Completion date

2013-09-30

Last updated

2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy subjects through the alteration in the pharmacokinetic and pharmacodynamic parameters (measurement of serum levels of G-CSF and absolute neutrophil count - ANC).

Interventions

DRUGFilgrastim

filgrastim, single dose, s.c., dosage: 5 mcg/kg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Agree with all study procedures, sign and date back by their own free will, the IC; * Be between 18 and 50 years, of both sexes; * Present a body mass index (BMI) greater than or equal to 20 and less than or equal to 28; * are considered healthy, clinical, psychological and laboratory; * are female, but they have and maintain a safe method of contraception during the study.

Exclusion criteria

* Known hypersensitivity to filgrastim; * Hypersensitivity to products derived from E. coli; * fever or infectious disease in the 07 days preceding the first administration; * Positive serology for hepatitis B or C and HIV; * Prior treatment with CSFs, interleukins and interferons; * Participation in a clinical study in the last 12 months; * Donation or loss of blood in the 03 months preceding the study; * General anesthesia in the 03 months preceding the study; * Provide a history of alcohol abuse, drug or drugs; * Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological, psoriasis, gout, acute myocardial infarction, thyroid or psychiatric disease; * Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
The primary efficacy parameters will be based on the investigation of pharmacokinetics and pharmacodynamics of filgrastim in research subjects after administration of single dose via sc or iv routes at doses of 5 or 10 mcg/kg of the drug.	• PK.: 0, 15 min., 30 min., 45 min., 1h, 1h e 30min., 2h, 3h, 4h, 6h, 8h,10h, 12h, 16h, 24h and 48h. • PD (ANC): 0, 30 min., 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 32h, 48h, 72h, 96h and 120h

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026