Pharmacokinetics and Pharmacodynamics of the Interferon Beta-1a Produced by Laboratorio Quimico Farmaceutico Bergamo Compared to Interferon Beta-1a (Rebif - Merck Serono) in Healthy Subjects
Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Interferon beta-1a (Biological); Interferon beta-1a (Biological)
Phase: Phase 1
Status: Completed
Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
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).
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a.
Secondary outcome: Security: observation of adverse effects
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Lal Clinica Pesquisa E Desenvolvimento Ltda, Valinhos, SP 13270000, Brazil
Additional Information
Starting date: January 2011
Last updated: February 22, 2013
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