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.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01549301
First received: March 6, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

March 6, 2012
March 6, 2012
August 2012
November 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: • 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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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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.
Not Provided

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Subjects
  • Drug: Filgrastim
    filgrastim, single dose, s.c., dosage: 5 mcg/kg
  • Drug: Filgrastim
    filgrastim, single dose, s.c., dosage: 10 mcg/kg
  • Drug: Filgrastim
    Filgrastim, i.v., single dose, dosage: 5 mcg/kg
  • Drug: Filgrastim
    Filgrastim, i.v., single dose, dosage: 10 mcg/kg
  • Experimental: Group D 10 i.v.
    Two periods, crossover, single dose, i.v., 10 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
    Intervention: Drug: Filgrastim
  • Experimental: Group C 5 i.v.
    Two periods, crossover, single dose, i.v., 5 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
    Intervention: Drug: Filgrastim
  • Experimental: Group B 10 s.c.
    Two periods, crossover, single dose, s.c., 10 mcg/kg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
    Intervention: Drug: Filgrastim
  • Experimental: Group A 5 s.c.
    Two periods, crossover, single dose, s.c., 5 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
    Intervention: Drug: Filgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
128
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact: Alexandre Frederico, Dr (55) 19 38716399 alexandre@lalclinica.com.br
Brazil
 
NCT01549301
FILBLA1211I, Version 01 - 09/12/2011
Not Provided
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Not Provided
Not Provided
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP