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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

Page last updated: August 20, 2015

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