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Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.

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ClinicalTrials.gov Identifier: NCT01494779
Recruitment Status : Unknown
Verified September 2012 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
First Posted : December 19, 2011
Last Update Posted : September 25, 2012
Sponsor:
Information provided by (Responsible Party):
Azidus Brasil

Study Description
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Brief Summary:
The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect between two preparations of somatropin (T and C) after a single administration of 5 mg in healthy subjects by altering serum somatropin pharmacokinetic parameters (AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2) and pharmacodynamic (measurement of serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.).

Condition or disease Intervention/treatment Phase
GH Deficiency (GHD) Growth Retardation Drug: Somatropin Phase 1

Detailed Description:
Secondly, the investigators will observe the clinical safety and tolerability after single dose administration in subjects, by comparing clinical parameters and the incidence of adverse events between groups.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2013
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : August 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Somatropin Test
Somatropin of Blausiegel Indústria e Comércio Ltda.
 Drug: Somatropin
single subcutaneous dose of 5mg
Active Comparator: Saizen
Somatropin of Merck Serono
 Drug: Somatropin
single subcutaneous dose of 5mg


Outcome Measures
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Primary Outcome Measures :
  1. The primary efficacy endpoint will be based in the investigation of pharmacokinetics and pharmacodynamics of somatropin in research subjects after administration of single dose, sc, of the drug. [ Time Frame: PK: 0, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 9, 12, 15, 18, 24 hours. PD: 0, 6, 12, 24 hours. ]

    Pharmacokinetic evaluation will be based on data obtained from the average dosage of somatropin plasma. Thus, the time of collection facilities provide the pharmacokinetic parameters AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2, which will be compared between the two formulations.

    The quantification of serum somatropin kit will be performed by ELISA validated using human serum as a biological matrix.

    The evaluation of the pharmacodynamics will be performed by quantifying serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.



Secondary Outcome Measures :
  1. After administration of the drug will be evaluated for safety and tolerability of the drug through the presence of hematoma, pain, itching and local redness, as well as the incidence of adverse events directly related to somatropin. [ Time Frame: 15 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Research subjects who agree with all study procedures, sign and date, of their own free will, the IC;
  2. Research subjects were male, aged between 18 and 32 years;
  3. Research subjects with body mass index greater than or equal to 20 and less than or equal to 25;
  4. Considered healthy subjects, both clinical and laboratory.

Exclusion Criteria:

  1. Have donated or lost 450 mL or more blood in the 6 months preceding the study;
  2. Having participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
  3. Having made use of regular medication less than two weeks to interfere with the pharmacokinetics / pharmacodynamics of the drug under study, such as glucocorticoids, anabolic steroids, androgens, estrogens and thyroid hormones;
  4. Present history of alcohol abuse, drug or drugs;
  5. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematologic, or psychiatric;
  6. Have made previous use of somatropin;
  7. Make use of energy supplements and / or be frequent consumers of soy products (eg replacement of animal milk for soy milk).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494779


Contacts
Contact: Alexandre Frederico, physian 55 19 3871-6399 alexandre@lalclinica.com.br

Locations
Brazil
LAL Clínica Pesquisa e Desenvolvimento Ltda Not yet recruiting
Valinhos, São Paulo, Brazil
Contact: Alexandre Frederico, phsycian    55 19 3871-6399    alexandre@lalclinica.com.br   
Principal Investigator: Alexandre Frederico, phsycian         
Sponsors and Collaborators
Azidus Brasil
More Information
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Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT01494779     History of Changes
Other Study ID Numbers: SOMBLA0911
Version 1
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012

Keywords provided by Azidus Brasil:
children