Bacterial Infections
Conditions
Interventions
This is a randomized, controlled, four-arm, double-blind clinical study with 36 participants allocated by randomization performed by the Sealed Envelope® software, with stratification by age, sex and
Sponsors
Universidade Evangélica de Goiás
Universidade Evangélica de Goiás
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Healthy adult men and women of non-childbearing potential. aged 18 to 55 years. Body mass index between 18.5 kilograms per square meter and 29.9 kilograms per square meter and body weight between 55.0 kilograms and 100.0 kilograms. No clinically significant abnormalities at screening or on Day 1, including vital signs within normal parameters (temperature, Normal heart rate, respiratory rate, and blood pressure), Normal electrocardiograms, hemoglobin/hematocrit, white blood cell count and platelet count greater than or equal to the lower limit of normal, serum creatinine less than 1.4 milligrams per deciliter, serum urea nitrogen less than 40 milligrams per deciliter, alanine aminotransferase and aspartate aminotransferase less than 50 units per liter
Exclusion criteria
Exclusion criteria: History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease that may increase the risk of adverse effects from study medications. History of confirmed or suspected Clostridium difficile infection. History of seizure disorders. Positive urine drug or alcohol test during screening. Positive test for human immunodeficiency virus (HIV), Positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). History of substance or alcohol abuse that increases the risk of adverse effects from study medications. Use of any prescription or over-the-counter medication; use of herbal products; use of vitamins; use of dietary supplements or hormonal supplements in the seven days prior to randomization. Documented hypersensitivity or anaphylaxis to any medication. Donation of blood or plasma in the thirty days prior to randomization, total blood loss greater than 500 milliliters in the thirty days prior to randomization, or blood transfusion in the one year prior to study enrollment. Participation in a clinical trial involving a New Chemical Entity in the last three months or a marketed drug in the thirty days prior to the first dose of the study drug. Any other condition or prior therapy that would make the volunteer unsuitable for the study, inability to fully comply with the study protocol or likely non-compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of the combination Ceftibuten + Polymyxin B in healthy adults, measured by the incidence, type and severity of adverse events (AEs) and serious adverse events (SAEs) during and after administration of multiple doses, as well as by relevant clinical and laboratory changes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events with description of the type and frequency of adverse events observed; summary of the type and frequency of concomitant medication administered during the study; variation in body temperature expressed in degrees Celsius and Fahrenheit | — |
Countries
Brazil
Contacts
Public ContactSimone Simionatto
Universidade Federla da Grande Dourados
Outcome results
None listed