drugset / Trial / NCT03634514
Non-inferiority Evaluation of Pain Intensity After Biomatrop (Somatropin) Application in Relation to Hormotrop (Somatropin), in Healthy Subjects
RandomizedCrossoverQuadruple-blindSupportive care
Summary
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.
Timeline
- Start
- 2018-08-27
- Primary completion
- 2018-09
- Completion
- 2018-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Biomatrop | Protein / enzyme biologic | 4 iu | Subcutaneous |
| Subject | Hormotrop | Protein / enzyme biologic | 4 iu | Subcutaneous |
Indications
No indication recorded.