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

NCT03634514 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2018-08-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ache Laboratorios Farmaceuticos S.A.

    lead INDUSTRY

Principal Investigators

  • Sérgio Alberto Cunha Vêncio · Instituto de Ciências Farmacêuticas (ICF)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-27
Primary Completion
2018-09-30
Completion
2018-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03634514 on ClinicalTrials.gov