Anemia
Conditions
Interventions
Admission of approximately 48 hours for subcutaneous administration of recombinant human erythropoietin test and comparator.
Fifty-two (52) healthy male participants (2 groups of 26 participants) will
Biological/vaccine
D27.505
Sponsors
Laboratório Daudt Oliveira Ltda.
CAEP - Centro Avançado de Estudos e Pesquisas
Synova Pesquisa Científica Ltda.
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Informed Consent Form approved by IRB signed; male; age between 18 and 55 years; be characterized as a healthy research participant from medical history, general physical examination and vital signs, laboratory tests and ECG indicating no evidence of disease; have a BMI equal or greater than 18 and equal or less than 29.9 kg/m2; have a body weight of 60 - 100 kg; normal iron metabolism tests
Exclusion criteria
Exclusion criteria: Cardiovascular disorders and BP greater than 145/90 mmHg; history of venous thrombosis; presence of iron deficiency anemia or clinical history of autoimmune or hereditary anemia; clinical history of chronic or acute bleeding in the 30 days before the start of the trial; prior erythropoietin therapy; signs or clinical history of spinal cord aplasia; changes in the electrocardiogram that, at the physician's discretion, does not recommend the participant's stay in the trial; have a history of excessive alcohol consumption for at least 6 months prior to the trial (drinking 5 or more alcoholic beverages in one day or 15 or more alcoholic beverages per week); be a smoker or have quit smoking for less than 6 months; participant who consumes 5 or more cups of tea or coffee per day and cannot abstain during the trial period; participants with chronic diseases; hypersensitivity or contraindication of using the components of the medications studied; blood donation (more than 500 mL) or major surgery within 3 months prior to signing the Informed Consent Form; participation in clinical trial protocols in the last 12 months; any clinical condition or laboratory abnormality which, at the discretion of the investigator, could compromise trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetic profile by quantifying the following parameters: AUC0-t (Area under the Curve), Cmax (maximum concentration), Tmax (maximum time) and T½ (half-life) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacodynamic profile through reticulocyte count, hemoglobin (Hb) and hematocrit;To evaluate the safety from adverse events and serious adverse events obtained through spontaneous reports, clinical, physical evaluations and laboratory tests | — |
Countries
Brazil
Contacts
Public ContactMichele Espíndola
Laboratório Daudt Oliveira Ltda.
Outcome results
None listed