Bioavailability Pilot Study of Versus W0035 Versus Stromectol

Comparative Bioavailability Pilot Study of 3 W0035 Test Oral Suspensions (Ivermectin 1mg/mL) Versus Stromectol® (Ivermectin, 3 mg Tablet) After Single Oral Administration in Healthy Volunteers. Single Centre, Open Label, Crossover, Randomized, 5-period, 20-sequence, Partial Replicate, Single Dose Design

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.

Inclusion Criteria:

• 18.5 ≤ BMI ≤ 30.0 kg/m².
• Non-smoker subject with a breath carbon monoxide reading of ≤10 ppm at screening.
• Agree to use effective contraception method

Exclusion Criteria: most specific out of 30.

• History of or current symptomatic orthostatic hypotension
• Hyper-eosinophilia or subject at risk of microfilaremic disease or clinical suspicion of intestinal helminth infection
• History of or current macroscopic or microscopic hematuria
• Positive serology for Hepatitis Bs antigen (HBs), Hepatitis C Virus (HCV) and HIV 1 and 2 antibodies.
• Organic disorder likely to modify, absorption, distribution or elimination of the medication.