Study of Pegfilgrastim similar in Healthy Participants.
- Conditions
- eutropeniaC15.378.553.546.184.564
- Registration Number
- RBR-6wdrhw
- Lead Sponsor
- CAEP - Centro Avançado de Estudos e Pesquisas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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