Bioavailability Pilot Study of Versus W0035 Versus Stromectol

Pierre Fabre

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ivermectin T2; Drug: ivermectin T3; Drug: ivermectin T1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03717558

W00035 PU 1 02

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Stromectol R

Active Comparator group

Description:

Stromectol R = ivermectin 3mg (tablet)

Treatment:

Drug: ivermectin T3

Drug: ivermectin T2

Drug: ivermectin T1

ivermectin T1

Experimental group

Description:

T1= ivermectin low grade particle Size Distribution

Treatment:

Drug: ivermectin T3

Drug: ivermectin T2

Drug: ivermectin T1

ivermectin T2

Experimental group

Description:

T2= ivermectin medium grade particle Size Distribution

Treatment:

Drug: ivermectin T3

Drug: ivermectin T2

Drug: ivermectin T1

ivermectin T3

Experimental group

Description:

T= ivermectin high grade particle Size Distribution

Treatment:

Drug: ivermectin T3

Drug: ivermectin T2

Drug: ivermectin T1