NCT04854460

Bioequivalence Study 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)

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) in Healthy Adults Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Revemact	1 tablet contains 6 mg Ivermecin
DRUG	Stromectol (first dose)	2 tablet contain 6 mg Ivermecin
DRUG	Stromectol (second dose)	2 tablet contain 6 mg Ivermecin

Timeline

• Start date: 2021-01-28
• Primary completion: 2021-02-25
• Completion: 2021-03-22
• First posted: 2021-04-22
• Last updated: 2021-04-27

Locations

1 site across 1 country: Egypt