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National, Monocentric, Randomized, Double-blind, Controlled, Crossover Clinical Trial, to Evaluate the Non-inferiority of Pain Intensity After the Application of Recombinant Human Somatropin - Biomatrop (Biosintética Farmacêutica) in Relation to Recombinant Human Somatotropin - Hormotrop (Bergamo), Single Dose, in Healthy Subjects of Both Genders
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.
Details
| Lead sponsor | Ache Laboratorios Farmaceuticos S.A. |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 68 |
| Start date | 2018-08-27 |
| Completion | 2018-10 |
Conditions
- Healthy Subjects
Interventions
- Recombinant human growth hormone - Biomatrop
- Recombinant human growth hormone - Hormotrop
Primary outcomes
- Pain Intensity — 1 hour
Report the Pain Intensity using Visual Analogue Scale (0-10cm)
Countries
Brazil