Hormonal
A domestic synthetic semaglutide product (Quincenta) demonstrates bioequivalence, comparable pharmacokinetics, and a similar safety/tolerability profile to the reference originator product (Ozempic) in healthy volunteers.
This study confirms that a specific domestic version of semaglutide (Quincenta) behaves in the body similarly to the brand-name version (Ozempic) when given as a single 0.5 mg dose to healthy people. It had no adverse effects and was not immunogenic. This supports the safety and interchangeability of this specific domestic product with the originator.
The results of the clinical study demonstrated the bioequivalence of the test drug and the reference drug... The tolerability of the drugs in the volunteers was notified as good. No adverse events were recorded during the study.
Why this rating
Randomized, parallel, controlled clinical trial with healthy volunteers (n=54), though limited by single-dose design and healthy population.
Source
Comparative analysis of physicochemical properties, bioequivalence, safety and tolerability of the first domestic semaglutide
Ametov As et al. · Pharmacy & Pharmacology · 2024
DOI 10.19163/2307-9266-2023-11-4-324-346
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