A Phase 1 interventional study of Interferon beta-1a and Interferon beta-1a in Healthy, sponsored by Azidus Brasil. Completed at 1 site in Brazil. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-25.
Sponsored by Azidus Brasil · Phase 1 and Interventional
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).
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.
Azidus Brasil is the lead sponsor of 78 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bergamo - Interferon beta-1a
Biological: Interferon beta-1a
Merck Serono - Interferon beta-1a
Biological: Interferon beta-1a
12.000UI - single dose
12.000UI - Single dose
Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a.
Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification
Time frame: 168 hours
Security: observation of adverse effects
Time frame: 168 hours
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Azidus Brasil