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Objective:
Primary objective of the present study was to assess the relative bioavailability of Alfuzosin 10 mg Prolong-released Tablets under Fed conditions, in Healthy Thai Male Volunteers after an oral administration with 7 days washout period.
Study Design:
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study
Full description
This study is conducted to investigate bioequivalence information which is required to ensure therapeutic equivalence of a test product and a reference product as well as to be considered as one aspect of product quality. Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
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Primary purpose
Allocation
Interventional model
Masking
44 participants in 2 patient groups
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Central trial contact
Nannapat Wannaphruek; Thanaporn Wongyai
Data sourced from clinicaltrials.gov
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