Conditions: Infections, Urinary Tract
Keywords: Bioequivalence film coated tablets cefadroxil
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief 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 \&amp;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.

Detailed description:

Arms:
arm 1: Subjects will receive a single oral dose of cefadroxil tablet manufactured by GSK under fasting condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of cefadroxil tablet manufactured by NP under fasting condition in treatment period 2 arm 2: Subjects will receive a single oral dose of cefadroxil tablet manufactured by NP under fasting condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of cefadroxil tablet manufactured by GSK under fasting condition in treatment period 2

Interventions: intervention 1: Cefadroxil tablets manufactured by GSK intervention 2: Cefadroxil tablets manufactured by NP
Intervention descriptions: intervention 1: Cefadroxil tablets manufactured by GSK contains 1 mg of Cefadroxil intervention 2: Cefadroxil tablets manufactured by NP contains 1 mg of Cefadroxil

Protocol document: