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.

NCT01549301 | Completed Phase 1

• 2 other identifiers: FILBLA1211IVersion 01 - 09/12/2011
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (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.

  • 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

Study Arms (4)

Group D 10 i.v.

EXPERIMENTAL

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

Group C 5 i.v.

EXPERIMENTAL

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

Group B 10 s.c.

EXPERIMENTAL

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

Group A 5 s.c.

EXPERIMENTAL

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

Interventions

Filgrastim DRUG

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

Group A 5 s.c.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Location

MeSH Terms

Interventions

Filgrastim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 20, 2018

Record last verified: 2018-01

Locations

BR (1)