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

NCT03634514 | Unknown Phase 4

• 1 other identifier: PPES 002/18
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Report the Pain Intensity using Visual Analogue Scale (0-10cm)

  1 hour

Study Arms (2)

Application of Biomatrop

EXPERIMENTAL

A single dose of Recombinant Human Somatropin - Biomatrop is administered. The pain intensity is evaluated using visual analogue scale (0-10cm) and record the incidence of adverse events.

Drug: Recombinant human growth hormone - Biomatrop; Drug: Recombinant human growth hormone - Hormotrop

Application of Hormotrop

ACTIVE COMPARATOR

A single dose of Recombinant Human Somatropin - Hormotrop is administered. The pain intensity is evaluated using visual analogue scale (0-10cm) and record the incidence of adverse events.

Drug: Recombinant human growth hormone - Biomatrop; Drug: Recombinant human growth hormone - Hormotrop

Interventions

Recombinant human growth hormone - Biomatrop DRUG

The subjects who recieve Biomatrop first, after a period maximum of 24 hours will recieve a dose of Hormotrop.

Application of Biomatrop; Application of Hormotrop

Recombinant human growth hormone - Hormotrop DRUG

The subjects who recieve Hormotrop first, after a period maximum of 24 hours will recieve a dose of Biomatrop.

Application of Biomatrop; Application of Hormotrop

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Skin phototype from 2 to 4, according to Fitspatrick classification: http://www.sbd.org.br/dermatologia/pele/cuidados/classifica cao-dos-fototipos-de-pele/ ;
• Subjects with normal laboratory, type 1 urine exam, vital signs and ECG results;
• Weight ≥ 50kg and Body Mass Index ≤ 30 ;
• Healthy subject according with clinical history
• Ability to understand and consent their participation in this clinical study, expressed by signing the Informed Consent Form (ICF);
• Subject who have negative results for stool protoparasitological examination accomplished in clinical study. Subjects with positive results for Endolimax nana, Entamoeba hartmanni, Entamoeba coli, Iodamoeva btshlii, Chilomastix mesili, Trichomonas hominis, Retortamonas intestinalis e Enteromonas hominis will be able to be included in the study. At the end of the study those subjects will be guided to treatment according to clinic investigator criteria.

You may not qualify if:

• Laboratory and clinical exam results out of normal range values, unless considered by physician clinically irrelevant;
• Positive sorology for HIV;
• Positive sorology for Hepatitis B;
• Positive sorology for Hepatitis C;
• Known hypersensitivity to the components of the medicines used during the study or related chemical compounds;
• Subjects that has participated in clinical trial protocols in the last twelve (12) months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;
• History of alcohol abuse or having ingested alcoholic drink 24 hours prior to IP administration;
• History of psychotropic drug use and / or positive outcome for any of the components of the drug abuse test for amphetamine, benzoylecgonine (cocaine), benzodiazepines, methamphetamine, opiates, morphine, etrahydrocannabinol-THC (Marijuana / Marijuana). Subjects who used marijuana and hashish in less than three months before the consultation will be excluded. For drugs like cocaine, crack and heroin will be excluded subjects who present any use history;
• Any finding of clinical observation, laboratory abnormality or therapy which, in the opinion of the investigator, may put the subject at risk or interfere with the purpose of the study;
• The subject have any condition that in investigator's opinion prevents him/her from participating in the study;
• History of food allergy or hyperactivity to medications or food;
• Regular smokers or ex-smokers who have stopped for less than 6 months;
• Subjects who have a relationship of kinship to second degree or any bond with the sponsor or research center employees;
• Subjects with the following ECG changes: sinus tachycardia with heart rate ˃ 120 bpm; bradycardia sinus heart rate \<50 bpm; atrial tachycardia, ventricular or junctional; ectopic atrial rhythm; atrial fibrillation; atrial flutter; accelerated idioventricular rhythm; locking atrium ventricular (BAV) of 1º, 2º and 3º degrees; ventricular pre-excitation; complete blockage of right or left branch; rhythm of pacemaker; supraventricular tachycardia (nodal tachycardia, ventricular atrial tachycardia) or any other clinically significant;
• Male subjects who do not agree to use acceptable contraceptive methods: (a) contraceptive methods for the participant: barrier preservative, except for (vasectomy) or for participants who declare that they do not engage in sexual practices or exercise them non-reprodutively; (b) contraceptive methods for the partner: oral contraceptive, intravenous contraceptive, intrauterine device (IUD), hormonal implant, hormonal transdermal patch, tubal ligation, and barrier methods except for female partners that are surgically sterile (bilateral oophorectomy or hysterectomy), or menopause for at least 01 (one) year;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (1)

Instituto de Ciências Farmacêuticas

Goiânia, Goiás, Brazil

Location

Study Officials

• Sérgio Alberto Cunha Vêncio

  Instituto de Ciências Farmacêuticas (ICF)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisangela Rorato

CONTACT

+55 11 2608-6130; Elisangela.rorato@ache.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 16, 2018
• Study Start: August 27, 2018
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

BR (1)