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.

Azidus

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Filgrastim

Study type: Interventional

Funder types: Industry

Identifiers

NCT01549301

FILBLA1211I

Version 01 - 09/12/2011

Details and patient eligibility

About

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).

Enrollment: 128 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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128 participants in 4 patient groups

Group D 10 i.v.

Experimental group

Description:

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.

Treatment:

Drug: Filgrastim

Drug: Filgrastim

Drug: Filgrastim

Drug: Filgrastim

Group C 5 i.v.

Experimental group

Description:

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.

Treatment:

Drug: Filgrastim

Drug: Filgrastim

Drug: Filgrastim

Drug: Filgrastim

Group B 10 s.c.

Experimental group

Description:

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.

Treatment:

Drug: Filgrastim

Drug: Filgrastim

Drug: Filgrastim

Drug: Filgrastim

Group A 5 s.c.

Experimental group

Description:

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.

Treatment:

Drug: Filgrastim

Drug: Filgrastim

Drug: Filgrastim

Drug: Filgrastim