drugset / Trial / NCT03717558

Bioavailability Pilot Study of Versus W0035 Versus Stromectol

NCT03717558

Phase 1 Withdrawn Pierre Fabre Dermatology
RandomizedCrossoverOpen-labelOther

Summary

Ivermectin is prescribed for the treatment of helminthic infections sensitive to ivermectin. However, it is currently only available as a tablet formulation. W0035 is a powder for oral suspension of ivermectin developed by PIERRE FABRE DERMATOLOGIE intended to be administered to children for the treatment of helminthic infections sensitive to ivermectin and mentioned in the Summary of Product Characteristics (SmPC) of Stromectol. PIERRE FABRE DERMATOLOGIE intends to carry out this pilot bioavailability study in order to define the most appropriate formulation to be used in the bioequivalence study.

Timeline

Start
2018-04-30
Primary completion
2018-04-30
Completion
2018-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivermectin Small molecule 3 mg Oral

Indications

No indication recorded.