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Randomized, Double-blind, Controlled, Crossover, in which 68 subjects (34 males and 34 females) will receive, in each stage, an application of 4 UI, subcutaneous, single dose, of the investigational drug (Recombinant Human Somatropin - Biomatrop) and the comparator (Recombinant Human Somatropin - Hormotrop) according to randomization to evaluate the Non-inferiority of Pain Intensity After the Application of Hormotrop, using Visual Analogue Scale (0-10cm) and record the incidence of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Application of Biomatrop | Experimental | A single dose of Recombinant Human Somatropin - Biomatrop is administered. The pain intensity is evaluated using visual analogue scale (0-10cm) and record the incidence of adverse events. |
|
| Application of Hormotrop | Active Comparator | A single dose of Recombinant Human Somatropin - Hormotrop is administered. The pain intensity is evaluated using visual analogue scale (0-10cm) and record the incidence of adverse events. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human growth hormone - Biomatrop | Drug | The subjects who recieve Biomatrop first, after a period maximum of 24 hours will recieve a dose of Hormotrop. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Report the Pain Intensity using Visual Analogue Scale (0-10cm) | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisangela Rorato | Contact | +55 11 2608-6130 | Elisangela.rorato@ache.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Sérgio Alberto Cunha Vêncio | Instituto de Ciências Farmacêuticas (ICF) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Ciências Farmacêuticas | Goiânia | Goiás | Brazil |
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| Recombinant human growth hormone - Hormotrop | Drug | The subjects who recieve Hormotrop first, after a period maximum of 24 hours will recieve a dose of Biomatrop. |
|