Palatability of a Novel Oral Formulation of Prednsione

Arkansas Children's Hospital Research Institute

Status: Completed

Conditions: Palatability

Study type: Observational

Funder types: Other

Identifiers

NCT02233959

Orbis Palatability

Details and patient eligibility

About

Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone to pediatric and adult patients. The rationale for this study is that palatability is the most important determinant of pediatric patient compliance, and therefore, it is critical that the Orbis formulation be perceived as significantly more palatable compared to today's commercially available products in order to warrant further development of the TP.

Enrollment: 24 patients

Sex: All

Ages: 18 to 32 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 18 to 32 years, male and female who are healthy at the time of study
• can demonstrate holding 10 mL of apple juice in mouth for 5 seconds without swallowing and then expectorate contents into a cup
• demonstrate ability to complete study questionnaire

Exclusion criteria

• history of smoking or using any tobacco products
• previous history of taste disturbance
• any condition or dietary habit known to interfere with the sense of smell and taste
• any structural or functional abnormality of the upper gastrointestinal tract
• ingestion of any medication or nutritional supplement (with exception of acetaminophen tablets or capsules) in a 48 hour period prior to study
• history of any significant illness within the two weeks prior to study
• history of autonomic dysfunction, bronchospastic disease or atopic allergy
• known hypersensitivity (ie., allergic reaction) to any drug, food coloring agent or artificial sweetener
• any history of participating in a clinical trial of a drug or device within a 30 day period from the time of study
• brushing of the teeth, usage of mouthwash, and or oral ingestion of any substance within two hours of receipt of the initial test article and
• inability to speak and/or read English at a grade 10 level

Trial design

24 participants in 1 patient group

Healthy Adults