Neutropenia
Conditions
Interventions
Admission of approximately 48 hours for subcutaneous (sc) administration of pegfilgrastim test and comparator.
48 healthy participants of both sexes will be randomized, who will receive both study dru
Biological/vaccine
Sponsors
CAEP - Centro Avançado de Estudos e Pesquisas
Inovatie Consultoria e Serviços em Saúde Ltda - ME
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Sign the TCLE approved by the CEP; Participants of both sexes between the ages of 18 and 55; Participant must be physically and mentally healthy through information collected from medical history, general physical examination and vital signs, laboratory tests and electrocardiogram not indicating any evidence of disease; Body mass index (BMI) greater than or equal to 18.5 and less than or equal to 29.9 kg / m2.
Exclusion criteria
Exclusion criteria: Diagnosis of malignant disease in the last 5 years, except for successful basal cell carcinoma; Prior diagnosis of severe asthma, sickle-cell anemia or anaphylaxis; Laboratory alteration (at the discretion of the researcher) of any nature that could compromise participation in the study; Use of legal or illegal drugs; Hypersensitivity or contraindication of use to the components of the medications studied; Participation in another clinical study in a period of less than 1 year (unless justified by the researcher); Women of childbearing age without adequate contraception, pregnant or breastfeeding; Blood donation (greater than 500 mL) in the preceding 3 (three) months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the pharmacokinetic parameter ASC (0-t) (Area under the curve from zero blood collection time to the last quantifiable point of the curve);;Evaluation of the pharmacokinetic parameter Cmax (Maximum concentration); measured from time 0 to the 16th day.;Evaluation of the pharmacokinetic parameter T1 / 2 (half-life time), from time 0 to the 16th day | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacodynamic activity of absolute neutrophil counts (CAN), obtained from the complete blood count from 0 to 16 days.;change in CD34 + cell count, obtained from blood collection, from time 0 to the 16th day;product safety data, evaluated by the number of adverse events in the study, reported up to the end of the study | — |
Countries
Brazil
Contacts
Public ContactMichele Espíndola
Laboratório Daudt Oliveira Ltda. (Mega Pharma)
Outcome results
None listed