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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.

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ClinicalTrials.gov Identifier: NCT01549301
Recruitment Status : Unknown
Verified March 2012 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
First Posted : March 9, 2012
Last Update Posted : March 9, 2012
Sponsor:
Information provided by (Responsible Party):
Azidus Brasil

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).

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Filgrastim Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2012
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

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U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Filgrastim
Filgrastim, i.v., single dose, dosage: 10 mcg/kg
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.
Drug: Filgrastim
Filgrastim, i.v., single dose, dosage: 5 mcg/kg
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.
Drug: Filgrastim
filgrastim, single dose, s.c., dosage: 10 mcg/kg
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.
Drug: Filgrastim
filgrastim, single dose, s.c., dosage: 5 mcg/kg



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549301


Contacts
Contact: Alexandre Frederico, Dr (55) 19 38716399 alexandre@lalclinica.com.br

Locations
Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil
Sponsors and Collaborators
Azidus Brasil

Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT01549301     History of Changes
Other Study ID Numbers: FILBLA1211I
Version 01 - 09/12/2011
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs