Healthy
Conditions
Keywords
PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A
Brief summary
The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect of two commercial preparations of interferon beta-1a (IFN Test: Lab Bergamo and IFN Comparator: Rebif ® - Merck Serono Lab) after single administration (12.000UI) in healthy subjects by modifying the parameters Cmax, Tmax and AUC (pharmacokinetics) and the levels of 2'5' oligoadenylate synthase and beta-2-microglobulin (pharmacodynamics).
Detailed description
Secondly, safety will be observed (tolerability) clinically after administration of a single dose in study subjects, by comparing the clinical and laboratory parameters before and after study and the incidence of adverse events.
Interventions
BIOLOGICALInterferon beta-1a
12.000UI - single dose
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Accepted Informed Consent 2. Study subjects male, aged 18 to 50 years; 3. Research subjects with body mass index greater than or equal to 19 and less than or equal to 30; 4. Subjects considered healthy, based on the analysis of the clinical history and clinical and laboratory data.
Exclusion criteria
1. Having donated or lost 450 mL or more of blood in the 6 months preceding the study; 2. Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study; 3. Having made regular use of medication in the 4 weeks prior to the start of the study or have made use of medications that interfere with the pharmacokinetics / pharmacodynamics of drugs studied a week before the start of the study; 4. Have been hospitalized for any reason, up to 8 weeks before the start of the study; 5. Demonstrate a history of alcohol abuse, drugs, or drugs, or have consumed alcohol within 48 hours prior to the period of hospitalization; 6. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric; 7. To present the pressure of any etiology requiring pharmacological treatment; 8. Display history of myocardial infarction, angina and / or heart failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a. | 168 hours | Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification |
Secondary
| Measure | Time frame |
|---|---|
| Security: observation of adverse effects | 168 hours |
Countries
Brazil
Outcome results
None listed