Bioavailability Pilot Study of Versus W0035 Versus Stromectol

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ivermectin T1
* Drug: ivermectin T2
* Drug: ivermectin T3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Open label, crossover, randomized, 5-period, 20-sequence, partial replicate, single dose design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stromectol R<br>Stromectol R = ivermectin 3mg (tablet) | Drug: ivermectin T1<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>Drug: ivermectin T2<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>Drug: ivermectin T3<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>|
| Experimental: ivermectin T1<br>T1= ivermectin low grade particle Size Distribution | Drug: ivermectin T1<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>Drug: ivermectin T2<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>Drug: ivermectin T3<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>|
| Experimental: ivermectin T2<br>T2= ivermectin medium grade particle Size Distribution | Drug: ivermectin T1<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>Drug: ivermectin T2<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>Drug: ivermectin T3<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>|
| Experimental: ivermectin T3<br>T= ivermectin high grade particle Size Distribution | Drug: ivermectin T1<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>Drug: ivermectin T2<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>Drug: ivermectin T3<br>* Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of ivermectin | At each period: 17 blood samples: T0 (Pre-dose), T0 +15min, T0 +30min, T0 +1h, T0+1h30min, T0 +2h, T0 +2h30, T0 +3h, T0 +3h30, T0 +4h, T0 +4h30, T0 +5h, T0 +6h, T0 +12h, T0 +24h, T0 +48h and T0 +72h | 5 periods of 3 days each |