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.

Healthy Subjects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549301
• Other study ID #: FILBLA1211I
• Secondary ID: Version 01 - 09/
• Status: Completed
• Phase: Phase 1
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: January 2018
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
Brazil	LAL Clinica Pesquisa e Desenvolvimento Ltda	Valinhos	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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