Overview

Non-inferiority Evaluation of Pain Intensity After Biomatrop (Somatropin) Application in Relation to Hormotrop (Somatropin), in Healthy Subjects

Status:
Unknown status

Trial end date:
2018-10-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 4

Details

Lead Sponsor:

Ache Laboratorios Farmaceuticos S.A.

Treatments:

Hormones