Healthy Subjects
Conditions
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.
Interventions
DRUGRecombinant human growth hormone - Biomatrop
The subjects who recieve Biomatrop first, after a period maximum of 24 hours will recieve a dose of Hormotrop.
DRUGRecombinant human growth hormone - Hormotrop
The subjects who recieve Hormotrop first, after a period maximum of 24 hours will recieve a dose of Biomatrop.
Sponsors
Ache Laboratorios Farmaceuticos S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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; * Use of any type of regular medication within two (2) weeks or five (5) half-lives (whichever lasts longer) before administration of the first dose of the investigational product (IP). The eventual use of medication, which in the opinion of the Principal Investigator or physician does not interfere with the pharmacokinetics of IP in study will not be considered as
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 1 hour | Report the Pain Intensity using Visual Analogue Scale (0-10cm) |
Countries
Brazil
Contacts
Primary ContactElisangela Rorato
Outcome results
None listed