Bioequivalence of the 4-mg Oral Granules and Chewable Tablet Formulations of Montelukast

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Bioequivalence of the 4-mg Oral Granules and Chewable Tablet Formulations of Montelukast

PURPOSE: The primary objective of the studies was to demonstrate bioequivalence between the oral granules formulation and chewable tablet of montelukast in the fasted state. Effect of food on the pharmacokinetics of the oral granules was also evaluated. METHODS: The Formulation Biocomparison Study (Study 1) and the Final Market Image Study (Study 2) each used an open-label, randomized, 3-period...

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ژورنال

عنوان ژورنال: Archives of Drug Information

سال: 2010

ISSN: 1753-5174,1753-5174

DOI: 10.1111/j.1753-5174.2010.00029.x