(via TheNewswire)
The Study is a three-arm, crossover investigation that will compare three 7 mg semaglutide dose formulations:
a positive control Rybelsusswallowed tablet (already dosed);
DehydraTECH-semaglutide swallowed capsules; and
for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.
The second DehydraTECH Study arm will use a Rybelsus® composition processed with DehydraTECH that is compliant with the
The acidic environment of the stomach seriously degrades GLP-1 drugs that are swallowed, resulting in exceptionally low blood absorption rates of less than 1% when an absorption technology is not used. For this reason, Lexaria’s final DehydraTECH Study arm will investigate an oral dissolvable tablet formulation, also compliant with the FDA IID, with DehydraTECH powered semaglutide from Ryblesus®. This will be the first study designed to investigate whether DehydraTECH-enhanced semaglutide can absorb at any level systemically into the sublingual/buccal tissues of the mouth and throat with fewer side effects than from swallowed administration, and with some effective drug delivery into the bloodstream.
In thepreviously announced human pilot studywith 7 volunteers,
About the Study
Design characteristics of the Study are similar in some ways to Lexaria’s initialhuman pilot study. The DehydraTECH-semaglutide test articles will be compound formulated using crushed Rybelsus® tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, and blood glucose levels. Blood samples will be taken multiple times during the first 10 hours post dosing; a final blood draw will be taken 24 hours after dosing; and a standardized meal will be fed to the test subjects at a point in time after dosing.Nine healthy subjects are expected to be dosed with each test article with roughly a 30-day “washout” interval between each dosing visit.
About Semaglutide
Rybelsus® (semaglutide) isthe only GLP-1 drug approved by the FDA for oral dosingto treat diabetes and weight loss. The FDA has also approved semaglutide marketed as Ozempic® and Wegovy®,administered by injection, to treat diabetes and weight loss. All three of these drugs are owned and manufactured by Novo Nordisk®.
About
DehydraTECH™ is Lexaria’s patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016,
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