Status:
COMPLETED
Vitamin Gum Pharmacokinetics
Lead Sponsor:
Penn State University
Collaborating Sponsors:
Vitaball, Inc.
Conditions:
Nutrient Pharmacokinetics
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The present study will investigate the oral release and systemic pharmacokinetics of a panel water- and fat-soluble vitamins from two commercially-produced chewing gum formulations. Vitaball, Inc. (Ft...
Detailed Description
Study Design The study will involve two phases. The first phase will be to compare the release of the component vitamins in two chewing gum products into the saliva. This will employ a parallel design...
Eligibility Criteria
Inclusion
- Men or women aged 18 - 60 yrs old in generally good health.
- Healthy oral cavity with no pre-existing oral diseases including cancer, periodontitis, or mucositis.
- No chewing or swallowing disorders.
- No known clotting disorders.
- Willingness to follow the investigator instructions and requirements of the protocol.
- Ability to give consent.
- Proficiency with the English language (both written and verbal)
Exclusion
- Pre-existing oral diseases including oral cancer, periodontitis, or mucositis.
- Chewing or swallowing disorder.
- Iron deficiency or anemia. The level of deficiency needed for exclusion will be at the discretion of the CRC physician associated with the study.
- Pregnant, lactating, or planning to become pregnant during the study.
- Phenylketonuric
- Medical, social, or economic circumstance which is likely to prevent adherence to the protocol.
Key Trial Info
Start Date :
October 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03230396
Start Date
October 13 2014
End Date
July 1 2015
Last Update
August 8 2017
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