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Sponsor decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stromectol R | Active Comparator | Stromectol R = ivermectin 3mg (tablet) |
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| ivermectin T1 | Experimental | T1= ivermectin low grade particle Size Distribution |
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| ivermectin T2 | Experimental | T2= ivermectin medium grade particle Size Distribution |
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| ivermectin T3 | Experimental | T= ivermectin high grade particle Size Distribution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ivermectin T1 | Drug | 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 |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria: most specific out of 30.
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| Name | Affiliation | Role |
|---|---|---|
| Karim Keddad, MD | Institut de Recherche Pierre Fabre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Nottingham | United Kingdom |
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Open label, crossover, randomized, 5-period, 20-sequence, partial replicate, single dose design
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| ivermectin T2 | Drug | 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 |
|
| ivermectin T3 | Drug | 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 |
|