NCT03634514

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Recombinant human growth hormone - Biomatrop	The subjects who recieve Biomatrop first, after a period maximum of 24 hours will recieve a dose of Hormotrop.
DRUG	Recombinant human growth hormone - Hormotrop	The subjects who recieve Hormotrop first, after a period maximum of 24 hours will recieve a dose of Biomatrop.

Timeline

• Start date: 2018-08-27
• Primary completion: 2018-09-01
• Completion: 2018-10-01
• First posted: 2018-08-16
• Last updated: 2018-08-17

Locations

1 site across 1 country: Brazil