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.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01494779
• Date of registration: 28/11/2011
• Prospective Registration: Yes
• Primary sponsor: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Public title: 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.
• Date of first enrolment: March 2013
• Target sample size: 32
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01494779
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Brazil

Contacts

• Name: Alexandre Frederico, physian

• Name: Alexandre Frederico, phsycian

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 32 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Growth Retardation

GH Deficiency (GHD)

Intervention(s)

Drug: Somatropin

Primary Outcome(s)

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.]

Secondary Outcome(s)

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]

Secondary ID(s)

SOMBLA0911

Version 1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors