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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.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01549301
First Posted: March 9, 2012
Last Update Posted: March 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Azidus Brasil
  Purpose
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 Intervention Phase
Healthy Subjects Drug: Filgrastim Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 128
Study Start Date: August 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT01549301     History of Changes
Other Study ID Numbers: FILBLA1211I
Version 01 - 09/12/2011
First Submitted: March 6, 2012
First Posted: March 9, 2012
Last Update Posted: March 9, 2012
Last Verified: March 2012

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