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Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Sofodelevier 400 mg F.C.T (Al-debeiky pharma, Egypt) versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 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 for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.
A comprehensive final report will be issued upon the completion of the study.
Sofodelevier, Sovaldi (fist dose), Sovaldi (second dose)
Genuine Research Center GRC
Genuine Research Center, Egypt
Published on BioPortfolio: 2017-02-24T15:23:21-0500
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