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Posted On: 12/14/2019 6:54:55 PM
Post# of 72440
Re: someconcerns #61437
The company spells it out clearly in the PR. They want to know where the Brilacidin gets released in the intestinal tract after pill ingestion. It's also to affirm safety and tolerability of the various doses. It's also to see whether it has systemic absorption or if, like Bril-UC, it does not enter the bloodstream in significant amounts.
Here's a blurb about gamma scintigraphy. Please note what I put in red:
Quote:
Objectives of the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation Phase 1 study of oral Brilacidin include:
• To visualize, using gamma scintigraphy:
the site of release of enteric coated delayed release tablets designed to target delivery of Brilacidin (50mg, 100mg, and 200mg) to the colon.
• the disintegration and dispersion of Brilacidin delayed release tablets in vivo.
• To evaluate the safety and tolerability of Brilacidin administered by delayed release tablet as single escalating doses.
• To assess systemic exposure/pharmacokinetics of Brilacidin following administration of delayed release tablets.
Here's a blurb about gamma scintigraphy. Please note what I put in red:
Quote:
What is Gamma Scintigraphy?
Gamma scintigraphy is a technique whereby the transit of a dosage form through its intended site of delivery can be non-invasively imaged in vivo via the judicious introduction of an appropriate short lived gamma emitting radioisotope. The observed transit of the dosage form can then be correlated with the rate and extent of drug absorption. Information such as the site of disintegration or dispersion can also be obtained. Assistance in product development as well as testing of finished products for corporate sponsors are commonly performed.
http://www.scintipharma.com/html/what_is_gamm...raphy_.htm
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