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An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Daktavira 60 mg film coated tablets ( European Egyptian Pharmaceutical Industries, Egypt) versus Daklinza 60 mg tablets (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition
Primary Pharmacokinetic Parameters: Cmax, 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.
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Genuine Research Center GRC
Genuine Research Center, Egypt
Published on BioPortfolio: 2016-02-07T18:30:41-0500
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