Obesity
Conditions
Interventions
Experimental group: 24 obese volunteers of both sexes will receive an oral Amoxicillin 875mg tablet, single dose with 200 mL of water as an aid to the ingestion of the drug.
Control group: 12 eutrophi
Drug
Sponsors
Hospital Universitário Regional de Maringá
Hospital Universitário Regional de Maringá
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Volunteers with obesity according to the classification proposed by the World Health Organization (BMI 30 to 40 kg / m²); being between 18 and 50 years old; have signed the consent form.
Exclusion criteria
Exclusion criteria: Intolerance or hypersensitivity to Amoxicillin and other antibiotics of the class; kidney or liver failure; pregnancy; breast-feeding; users of alcohol or illicit drugs; use of prokinetics (metoclopramide, erythromycin or domperidone); participation in clinical study in the last 3 months; have thrombocytopenia, anemia, heart disease, diabetes and / or hypertension, and endocrine disorders; being under 18 years old and over 50 years old; volunteers with difficulty in swallowing and / or presenting fistulas, significant stenosis or obstruction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Statistically significant difference (p <0.05) in the pharmacokinetic parameters of Amoxicillin between the obese and eutrophic group, which will be calculated from the concentration versus time curve. | — |
Secondary
| Measure | Time frame |
|---|---|
| Statistically significant difference (p <0.05) in pharmacokinetic parameters of Amoxicillin in the obese and eutrophic group when compared with literature data. | — |
Countries
Brazil
Contacts
Public ContactElza Grimshaw
Núcleo de Pesquisa Clínica e Bioequivalência
Outcome results
None listed