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.

NCT ID: NCT01549301

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Filgrastim

Intervention Type: DRUG

Filgrastim, i.v., single dose, dosage: 10 mcg/kg

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.

Group Type: EXPERIMENTAL

Filgrastim

Intervention Type: DRUG

Filgrastim, i.v., single dose, dosage: 5 mcg/kg

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.

Group Type: EXPERIMENTAL

Filgrastim

Intervention Type: DRUG

filgrastim, single dose, s.c., dosage: 10 mcg/kg

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.

Group Type: EXPERIMENTAL

Filgrastim

Intervention Type: DRUG

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

Interventions

Filgrastim

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

Intervention Type: DRUG

Filgrastim

filgrastim, single dose, s.c., dosage: 10 mcg/kg

Intervention Type: DRUG

Filgrastim

Filgrastim, i.v., single dose, dosage: 5 mcg/kg

Intervention Type: DRUG

Filgrastim

Filgrastim, i.v., single dose, dosage: 10 mcg/kg

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Version 01 - 09/12/2011

Identifier Type: -

Identifier Source: secondary_id

FILBLA1211I

Identifier Type: -

Identifier Source: org_study_id