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

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

Tracking Information

• First Submitted Date: November 13, 2009
• First Posted Date: February 24, 2010
• Last Update Posted Date: February 25, 2013
• Study Start Date: January 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

• Current Secondary Outcome Measures (submitted: October 26, 2010): Security: observation of adverse effects [ Time Frame: 168 hours ]
• Original Secondary Outcome Measures (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: 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: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label)
• Condition: Healthy

Intervention

• Biological: Interferon beta-1a
  12.000UI - single dose
• Biological: Interferon beta-1a
  12.000UI - Single dose

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2013): 20
• Original Estimated Enrollment (submitted: February 23, 2010): 12
• Actual Study Completion Date: July 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01074593
• Other Study ID Numbers: INTBER0609; VERSION 3
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
• Study Sponsor: Azidus Brasil
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Azidus Brasil
• Verification Date: February 2013