A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects
Status:
Completed
Trial end date:
2014-04-08
Target enrollment:
Participant gender:
Summary
This is an open-label, randomized, single dose, two-sequence two-period crossover study,
separated by 7 days washout interval from the first Study Drug Administration. This study is
conducted to determine the bioequivalence of cefadroxil from DURICEF™ film coated tablets
manufactured by Smithkline Beecham Egypt, LLC affiliated co. to GalaxoSmithKline (GSK) and
cefadroxil from BIODROXIL™ film coated tablets manufactured by Kahira Pharm &Chem .Ind.
Co . for Novartis Pharma (NP) after a single oral dose administration of each to healthy
adult subjects under fasting conditions. In Period 1, subjects will be randomized to receive
cefadroxil tablet manufactured by either GSK or NP. Following a washout of at least 7 days,
subjects will be crossed over in Period 2 to receive the cefadroxil tablet that they did not
receive in Period 1. DURICEF is a trademark of the GSK group of companies. BIODROXIL is a
trademark of Sandoz.