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KE, L-Lys-L-Glu, lysylglutamic acid

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Studies 40
Trials 100
Completed PHASE1 INTERVENTIONAL NCT02479867

A Bioequivalence Study of Cefadroxil From Duricef 1 gm F.C.T (GSK) and Biodroxil 1 gm F.C.T (Novartis Pharma)

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Cefadroxil from Duricef 1 gm Film Coated tablets(Smthkline Beecham Egypt,LLC affiliated co. to GalaxoSmithKline ) and Biodroxil 1 gm Film Coated tablets (Kahira Pharm \&Chem .Ind. Co . for Novartis Pharma ) after a single oral dose administration of each to healthy adults under fasting conditions.

Detailed Description

14 blood samples will be drawn in each period. The total volume of blood will not exceed 200 ml throughout the whole study. 0.00, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours., Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVAusing 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios forCmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.

Interventions

Name: Cefadroxil
Type: DRUG
Description: 1 tablet from test vs 1 tablet from reference

Primary Outcomes

Measure: Maximal measured plasma concentration (Cmax)
TimeFrame: 12 hours
Description: Serial blood samples for determination of study drug will be collected pre-dose and at 0.00 (pre-dose), 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours.

Trial Information

NCT ID

NCT02479867

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Genuine Research Center, Egypt

Last Updated

December 15, 2025