The biopharmaceutical studies of Valavir film-coated tablets, 0.5 g

S. N. Gureyeva, A. M. Goy, Ju. A. Kondratova, E. G. Oksamytna

Abstract


The biopharmaceutical studies of Valavir film-coated tablets, 0.5 g, with valaciclovir hydrochloride have been substantiated in the article. The biopharmaceutical studies have been conducted in vitro; the dissolution profiles of Valavir film-coated tablets, 0.5 g, and the reference drug Valtrex (film-coated tablets, 500 mg, manufactured by GlaxoSmithKline Pharmaceuticals S.A., Poland) have been compared by the method for Dissolution Kinetics. The results of the experimental study in vivo, namely the value of Cmax, AUC0-t and other values confirm that Valavir film-coated tablets, 0.5 g, manufactured by Farmak JSC is bioequivalent to the reference drug Valtrex film-coated tablets, 500 mg, (GlaxoSmithKline Pharmaceuticals S.A., Poland).

Keywords


biopharmaceutical studies; bioavailability; bioequivalence; test drug product; reference drug product; Valavir 0.5 g film-coated tablets

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References


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GOST Style Citations






DOI: https://doi.org/10.24959/88815

Abbreviated key title: Vìsn. farm.

ISSN 2415-8844 (Online), ISSN 1562-7241 (Print)