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 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).

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Filgrastim; Drug: Filgrastim; Drug: Filgrastim; Drug: Filgrastim

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Valinhos, Sao Paulo, Brazil
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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, single dose, s.c., dosage: 5 mcg/kg; Drug: Filgrastim; filgrastim, single dose, s.c., dosage: 10 mcg/kg; Drug: Filgrastim; Filgrastim, i.v., single dose, dosage: 5 mcg/kg; 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, single dose, s.c., dosage: 5 mcg/kg; Drug: Filgrastim; filgrastim, single dose, s.c., dosage: 10 mcg/kg; Drug: Filgrastim; Filgrastim, i.v., single dose, dosage: 5 mcg/kg; Drug: Filgrastim; Filgrastim, i.v., single dose, dosage: 10 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: 5 mcg/kg; Drug: Filgrastim; filgrastim, single dose, s.c., dosage: 10 mcg/kg; Drug: Filgrastim; Filgrastim, i.v., single dose, dosage: 5 mcg/kg; Drug: Filgrastim; Filgrastim, i.v., single dose, 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; Drug: Filgrastim; filgrastim, single dose, s.c., dosage: 10 mcg/kg; Drug: Filgrastim; Filgrastim, i.v., single dose, dosage: 5 mcg/kg; Drug: Filgrastim; Filgrastim, i.v., single dose, dosage: 10 mcg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (ESTIMATE): March 9, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: FILBLA1211I; Version 01 - 09/12/2011