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.

Study Overview
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Brief Summary
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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.).

Detailed Description
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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.

Conditions
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GH Deficiency (GHD), Growth Retardation

Intervention / Treatment
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* Drug: Somatropin
* Drug: Somatropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Research subjects who agree with all study procedures, sign and date, of their own free will, the IC; Research subjects were male, aged between 18 and 32 years; Research subjects with body mass index greater than or equal to 20 and less than or equal to 25; Considered healthy subjects, both clinical and laboratory. Exclusion Criteria: Have donated or lost 450 mL or more blood in the 6 months preceding the study; Having participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study; 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; Present history of alcohol abuse, drug or drugs; Have a history of liver disease, renal, pulmonary, gastrointestinal, hematologic, or psychiatric; Have made previous use of somatropin; Make use of energy supplements and / or be frequent consumers of soy products (eg replacement of animal milk for soy milk).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somatropin Test<br>Somatropin of Blausiegel Indústria e Comércio Ltda. | Drug: Somatropin<br>* single subcutaneous dose of 5mg<br>|
| Active Comparator: Saizen<br>Somatropin of Merck Serono | Drug: Somatropin<br>* single subcutaneous dose of 5mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children