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| ID | Type | Description | Link |
|---|---|---|---|
| Version 1 |
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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.).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin Test | Experimental | Somatropin of Blausiegel Indústria e Comércio Ltda. |
|
| Saizen | Active Comparator | Somatropin of Merck Serono |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | single subcutaneous dose of 5mg |
| |
| Somatropin |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Frederico, physian | Contact | 55 19 3871-6399 | alexandre@lalclinica.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL ClÃnica Pesquisa e Desenvolvimento Ltda | Valinhos | São Paulo | Brazil |
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| Drug |
single subcutaneous dose of 5mg |
|
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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