Clinical Study of Pharmacokinetics and Pharmacodynamics of the Drug Interferon Beta-1a Produced By Laboratorio Quimico Farmaceutico Bergamo Compared To Interferon Beta-1a (Rebif - Merck Serono) In Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Azidus Brasil
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Accepted Informed Consent
- •Study subjects male, aged 18 to 50 years;
- •Research subjects with body mass index greater than or equal to 19 and less than or equal to 30;
- •Subjects considered healthy, based on the analysis of the clinical history and clinical and laboratory data.
Exclusion Criteria
- •Having donated or lost 450 mL or more of blood in the 6 months preceding the study;
- •Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
- •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;
- •Have been hospitalized for any reason, up to 8 weeks before the start of the study;
- •Demonstrate a history of alcohol abuse, drugs, or drugs, or have consumed alcohol within 48 hours prior to the period of hospitalization;
- •Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
- •To present the pressure of any etiology requiring pharmacological treatment;
- •Display history of myocardial infarction, angina and / or heart failure.
Arms & Interventions
Comparator - Merck Serono
Merck Serono - Interferon beta-1a
Intervention: Interferon beta-1a (Biological)
Test
Bergamo - Interferon beta-1a
Intervention: Interferon beta-1a (Biological)
Outcomes
Primary Outcomes
Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a.
Time Frame: 168 hours
Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification
Secondary Outcomes
- Security: observation of adverse effects(168 hours)