NCT02479867

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

Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Cefadroxil From Duricef 1 gm F.C.T (GSK) and Biodroxil 1 gm F.C.T (Novartis Pharma)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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%.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2015-06-24
• Last updated: 2015-06-24

Locations

1 site across 1 country: Egypt