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.

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Sponsor:
Information provided by (Responsible Party):
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01494779
First received: November 28, 2011
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
GH Deficiency (GHD)
Growth Retardation
Drug: Somatropin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

    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:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: March 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 32 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01494779     History of Changes
Other Study ID Numbers: SOMBLA0911, Version 1
Study First Received: November 28, 2011
Last Updated: September 21, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
children

ClinicalTrials.gov processed this record on August 20, 2014