NCT01549301View on ClinicalTrials.gov

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.

PHASE1CompletedINTERVENTIONAL

Enrollment

128

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

August 31, 2013

Study Completion Date

September 30, 2013

Conditions

Healthy Subjects

Interventions

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

Trial Locations (1)

Unknown

LAL Clinica Pesquisa e Desenvolvimento Ltda, Valinhos

All Listed Sponsors

lead

Azidus Brasil

INDUSTRY

NCT01549301 - 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. | Biotech Hunter | Biotech Hunter