Healthy Volunteers
Conditions
Brief 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.
Interventions
DRUGivermectin T1
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
DRUGivermectin T2
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
DRUGivermectin T3
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
Sponsors
Pierre Fabre Dermatology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open label, crossover, randomized, 5-period, 20-sequence, partial replicate, single dose design
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of ivermectin | 5 periods of 3 days each | 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 |
Countries
United Kingdom
Outcome results
None listed