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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)

NCT04854460 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-27

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Eva Pharma

    collaborator INDUSTRY

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-28
Primary Completion
2021-02-25
Completion
2021-03-22

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04854460 on ClinicalTrials.gov