Healthy
Conditions
Keywords
pediatric taste test, antibiotic taste test, cefdinir, azithromycin
Brief summary
To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.
Detailed description
The Primary Purpose for the study is Other. Per ClinicalTrias.gov, more information regarding the primary purpose is described here; this study is a pediatric taste test.
Interventions
2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml
DRUGazithromycin
2.5 ml of cherry flavored oral suspension 100 mg/5 ml
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Female or male child age 4 through 8 years in good general health. * Minimum weight of 16.3 kg (36 lb). * Willing to comply with appropriate instructions provided to complete the study. * Written informed consent from parent/legal guardian.
Exclusion criteria
* Current medical condition, that in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, etc.). * History of allergic reaction to cefdinir, azithromycin, prescription (e.g. penicillins or cephalosporins) and/or OTC medications, and/or food products. * History of significant medical condition (e.g., GI disorders, hematological or bleeding disorders, renal or hepatic diseases). * Use of any oral medication, vitamins or herbal supplements within 6 hours prior to tasting. * Temperature \> than 99.2°F. Participation in a clinical or marketing research study within the past 3 months. * Sibling of another subject on the study, or living in the same household as another subject that has participated in a clinical or marketing research study within the past 3 months. * Family member or close friend employed by an advertising agency, market research company, and/or a company that processes or manufacturers medical or health care products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Taste and smell acceptance and preference | 2 hours |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events assessment | 72 hours with follow-up to a satisfactory conclusion |
| Concomitant Medications | 72 hours |
| Vital signs | 2 hours |
| Any clinically abnormal observations | 2 hours with follow-up to a satisfactory conclusion |
Countries
United States
Outcome results
None listed