(via TheNewswire)
First-ever dissolvable DehydraTECH-GLP-1 oral dose formulation to be tested
Rybelsussemaglutide will act as the positive control
The Study will be a randomized, crossover, placebo-controlled investigation that will compare three dose formulations each at a 7 mg semaglutide dose:
a positive control Rybelsusswallowed tablet;
DehydraTECH-semaglutide swallowed capsules; and,
for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.
Semaglutide swallowed into the stomach/intestine absorbs into the bloodstream at an exceptionally low rate typically atless than 1%,when it does not use any absorption technology because, in part, the acidic environment of the stomach is known to seriously degrade GLP-1 drugs.
“DehydraTECH has previously shown an ability to improve delivery of certain drugs destined for the bloodstream, through the buccal/sublingual tissues of the mouth and throat,” said
Manufacturing of the test articles for this Study is anticipated to be completed within 30 days.
CORRECTION
In Lexaria’spress release of
About the Study
Many design characteristics of the Study will be fundamentally the same as in 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.Eight healthy subjects areexpected to be dosed with each test article following a cross over study design across three study visits.
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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