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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

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ClinicalTrials.gov Identifier: NCT01074593
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : February 25, 2013
Sponsor:
Information provided by:
Azidus Brasil

Tracking Information
First Submitted Date  ICMJE November 13, 2009
First Posted Date  ICMJE February 24, 2010
Last Update Posted Date February 25, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2010)
  • Pharmacokinetics measured through plasma quantification [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours ]
  • Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin [ Time Frame: 0, 12, 24, 48, 72, 96, 120, 144, and 168 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
Security: observation of adverse effects [ Time Frame: 168 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2010)
Security: observation of adverse effects [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: Interferon beta-1a
    12.000UI - single dose
  • Biological: Interferon beta-1a
    12.000UI - Single dose
Study Arms  ICMJE
  • Experimental: Test
    Bergamo - Interferon beta-1a
    Intervention: Biological: Interferon beta-1a
  • Active Comparator: Comparator - Merck Serono
    Merck Serono - Interferon beta-1a
    Intervention: Biological: Interferon beta-1a
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2013)
20
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2010)
12
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01074593
Other Study ID Numbers  ICMJE INTBER0609
VERSION 3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
Study Sponsor  ICMJE Azidus Brasil
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azidus Brasil
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP