Pharmaceutical compositions of amlodipine and valsartan

A single layer pharmaceutical composition comprising active agent(s) amlodipine or a pharmaceutically acceptable salt thereof and valsartan or a pharmaceutically acceptable salt thereof wherein the composition exhibits bioequivalence to the commercially available bilayer tablet dosage form comprisin...

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Bibliographische Detailangaben
Hauptverfasser: AVACHAT MAKARAND KRISHNAKUMAR, MALEWAR NIKHIL PRABHAKAR, KUTE ANIRUDHA BHAGIRATH
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:A single layer pharmaceutical composition comprising active agent(s) amlodipine or a pharmaceutically acceptable salt thereof and valsartan or a pharmaceutically acceptable salt thereof wherein the composition exhibits bioequivalence to the commercially available bilayer tablet dosage form comprising amlodipine besylate and valsartan; when administered to human subject, under the bioequivalence parameters of a 90% Confidence Interval for AUC which is between 80% and 125%, and a 90% Confidence Interval for Cmax, which is between 80% and 125%.