Ivermectin Solution Bioequivalence Study - Fasted
Information source: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: ivermectin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Johnson & Johnson Consumer and Personal Products Worldwide Official(s) and/or principal investigator(s):
Jerry Cottrell, Study Director, Affiliation: McNeil UK
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Pharmacokinetic parameters, including AUC0-t, AUC0-inf and Cmax
Secondary outcome: Pharmacokinetic parameters, including t1/2, Mean residence time, Terminal Elimination Rate Constant, and Tmax
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Shandon Clinic, Cork, Co. Cork, Ireland
Additional Information
Starting date: March 2005
Last updated: October 4, 2011
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