Bioavailability Pilot Study of Versus W0035 Versus Stromectol
NCT ID: NCT03717558
Last Updated: 2018-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2018-04-30
2018-04-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Stromectol R
Stromectol R = ivermectin 3mg (tablet)
ivermectin 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
ivermectin 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
ivermectin 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
ivermectin T1
T1= ivermectin low grade particle Size Distribution
ivermectin 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
ivermectin 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
ivermectin 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
ivermectin T2
T2= ivermectin medium grade particle Size Distribution
ivermectin 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
ivermectin 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
ivermectin 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
ivermectin T3
T= ivermectin high grade particle Size Distribution
ivermectin 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
ivermectin 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
ivermectin 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
Interventions
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ivermectin 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
ivermectin 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
ivermectin 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
Eligibility Criteria
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Inclusion Criteria
* Non-smoker subject with a breath carbon monoxide reading of ≤10 ppm at screening.
* Agree to use effective contraception method
Exclusion Criteria
* 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.
18 Years
64 Years
MALE
Yes
Sponsors
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Pierre Fabre Dermatology
INDUSTRY
Responsible Party
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Principal Investigators
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Karim Keddad, MD
Role: STUDY_DIRECTOR
Institut de Recherche Pierre Fabre
Locations
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Quotient Clinical
Nottingham, , United Kingdom
Countries
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Other Identifiers
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W00035 PU 1 02
Identifier Type: -
Identifier Source: org_study_id
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