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Comparative bioequivalence of 1 mg and 4 mg tacrolimus extended-release tablets: randomized, open label, fully replicate, crossover trials in healthy adult subjects

IntroductionThese studies were planned to establish bioequivalence between two doses (1-mg and 4-mg) of test product (tacrolimus extended-release tablets manufactured by Intas Pharmaceuticals Ltd., India) with reference product (Envarsus XR® manufactured for Veloxis Pharmaceuticals, Inc., USA).Metho...

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Principais autores: Jay Kumar Sharma, Deepak Bunger, Hemant Zaveri, Alok Chaturvedi
Formato: Artigo
Idioma:Inglês
Publicado em: Frontiers Media S.A. 2026-06-01
coleção:Frontiers in Nephrology
Assuntos:
bioequivalence
crossover study
extended-release
open-label
pharmacokinetic
randomized trial
Acesso em linha:https://www.frontiersin.org/articles/10.3389/fneph.2026.1838510/full
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