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Trial record 19 of 102 for:    IVERMECTIN

Bioavailability Pilot Study of Versus W0035 Versus Stromectol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717558
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Dermatology

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: ivermectin T1 Drug: ivermectin T2 Drug: ivermectin T3 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Open label, crossover, randomized, 5-period, 20-sequence, partial replicate, single dose design
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Estimated Study Start Date : April 30, 2018
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Active Comparator: Stromectol R
Stromectol R = ivermectin 3mg (tablet)
Drug: 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

Drug: 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

Drug: 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

Experimental: ivermectin T1
T1= ivermectin low grade particle Size Distribution
Drug: 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

Drug: 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

Drug: 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

Experimental: ivermectin T2
T2= ivermectin medium grade particle Size Distribution
Drug: 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

Drug: 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

Drug: 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

Experimental: ivermectin T3
T= ivermectin high grade particle Size Distribution
Drug: 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

Drug: 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

Drug: 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




Primary Outcome Measures :
  1. Concentration of ivermectin [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717558


Locations
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United Kingdom
Quotient Clinical
Nottingham, United Kingdom
Sponsors and Collaborators
Pierre Fabre Dermatology
Investigators
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Study Director: Karim Keddad, MD Institut de Recherche Pierre Fabre

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Responsible Party: Pierre Fabre Dermatology
ClinicalTrials.gov Identifier: NCT03717558     History of Changes
Other Study ID Numbers: W00035 PU 1 02
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ivermectin
Antiparasitic Agents
Anti-Infective Agents