Clincosm LogoSign in Get a demo

Ivermectin Solution Bioequivalence Study - Fasted

Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide (Industry)
Overall Status
Completed
CT.gov ID
NCT00921154
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
6
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of ivermectin solution 1 mg/ml with a marketed reference formulation of ivermectin 3 mg tablets when taken after an overnight fast .The study is designed in accordance with the EU Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Ivermectin is an antiparasitic medicine (i.e. a medicine used to eliminate parasitic worms) for oral administration, and is approved in the US and some other countries in a tablet form. A new liquid formulation of ivermectin has been developed to facilitate dosing. This is a single dose, randomised, crossover study in healthy adult male and female volunteers, with doses taken after an overnight fast. Doses will be separated by washout period of at least 14 days. Twenty-one blood samples will be taken from each volunteer over 144 hours in each period. Concentrations of ivermectin in plasma will be measured using a validated chromatographic assay (LC-MS/MS). Standard pharmacokinetic parameters will be obtained and bioequivalence on the basis of rate and extent of drug absorption will be assessed.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Single-dose, Randomised, Crossover Study to Compare the Rate and Extent of Absorption of Two Formulations of Ivermectin in Healthy, Fasting Male and Female Volunteers
Study Start Date :
Mar 1, 2005
Actual Primary Completion Date :
May 1, 2005
Actual Study Completion Date :
Sep 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ivermectin

Ivermectin

Drug: ivermectin
Each subject will receive single doses of (i) 30 ml ivermectin oral solution (30 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods with a 14 day wash-out period. Doses will be administered after an overnight fast.
Other Names:
  • Stromectol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic parameters, including AUC0-t, AUC0-inf and Cmax [21 samples over 144 hours in each period]

    Secondary Outcome Measures

    1. Pharmacokinetic parameters, including t1/2, Mean residence time, Terminal Elimination Rate Constant, and Tmax [21 samples over 144 hours in each period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • BMI <= 30 kg/m2 Weight between 50 and 90 kg

    • Non-smokers, or smokers of fewer than 10 cigarettes per day

    • Clinically normal medical history and physical exam findings

    • Negative screening results for protocol-specified drugs of abuse

    • Negative HIV and Hepatitis B and C tests

    • Appropriate use of contraception and negative pregnancy test

    • Ability to comprehend and communicate effectively with investigative staff

    • Ability to give written informed consent

    Exclusion Criteria:

    • pregnant or nursing subjects

    • subjects who lived in region endemic for certain parasitic worm diseases

    • any protocol-specified vital sign or medical history that would preclude participation in the trial, including, but not limited to recent blood donation (or loss) and positive screens for HIV, Hepatitis B, or Hepatitis C

    • Any indication of current or previous abuse of alcohol, solvents or drugs

    • Intake of grapefruit products within 7 days before the start of the study

    • Intake of methylxanthine-containing beverages within 24 hours prior to each study period or quantities of methylxanthine or alcohol-containing beverages which, in the opinion of the Investigator are abnormal (more than 5 cups or glasses of tea, coffee, cola, chocolate etc. per day or more than 20 g alcohol/day)

    • Patients with a known or suspected intestinal helminth infection

    • Patients with a known hypersensitivity to any component of the Ivermectin product.

    • Smoking or alcohol consumption greater than protocol-specified levels

    • Protocol-specified contraindication to blood sampling

    • Acute or chronic medical, dietary or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shandon Clinic Cork Co. Cork Ireland

    Sponsors and Collaborators

    • Johnson & Johnson Consumer and Personal Products Worldwide

    Investigators

    • Study Director: Jerry Cottrell, McNeil UK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johnson & Johnson Consumer and Personal Products Worldwide
    ClinicalTrials.gov Identifier:
    NCT00921154
    Other Study ID Numbers:
    • SCO2704
    First Posted:
    Jun 16, 2009
    Last Update Posted:
    Oct 6, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide
    therapeutic equivalency
    pharmacokinetics
    fasting
    Healthy Volunteers
    Additional relevant MeSH terms:
    Ivermectin

    Study Results

    No Results Posted as of Oct 6, 2011