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Clinical Trial Summary

The objective of this investigation is to verify that ColdZyme® is deposited onto the throat and estimate the half-life of the ColdZyme® solution in the oropharynx of human volunteers using a log-linear mixed-effects model (LMM).


Clinical Trial Description

The study is an Open Label, Non-Comparative study intended to verify the method used to measure the duration of ColdZyme®. Each participant will be his own control as samples are taken before application of ColdZyme and used as an internal control. Samples will be taken from the oropharyngeal membrane using a cotton swab before application, and 1, 3, 5, 10, 20, and 60 minutes after application. Glycerol will then be extracted from the swabs using water and the concentration of glycerol will be measured. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03901846
Study type Interventional
Source Enzymatica AB
Contact
Status Completed
Phase N/A
Start date May 7, 2019
Completion date July 25, 2019

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