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Clinical Trial Summary

Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Ivermectin from Revemact 6 mg tablets (Man. by EVA Pharma for Horus for Pharmaceutical Industries, Egypt) and Stromectol 2*3 mg tablets (Merck Sharp & Dohme B.V., Haarlem, The Netherlands) after a single oral dose administration of each to healthy adults under fasting conditions.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04854460
Study type Interventional
Source Genuine Research Center, Egypt
Contact
Status Completed
Phase Phase 1
Start date January 28, 2021
Completion date March 22, 2021

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