- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00921674
Ivermectin Solution Bioequivalence Study - With Food
October 4, 2011 updated by: Johnson & Johnson Consumer and Personal Products Worldwide
A Single-dose, Randomised, Crossover Study to Compare the Rate and Extent of Absorption of Two Formulations of Ivermectin in Healthy Male and Female Volunteers After Food
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 a standard meal.
The study is designed in accordance with the EU Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001.
Study Overview
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 20 minutes after a standard breakfast.
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and female volunteers
- Aged between 18 and 50 years
- 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
- Clinically normal findings on physical examination
- Clinically normal blood pressure ( >/= 100/60 for males; >/= 90/50 for females; </= 140/90 for both)
- Electrocardiogram recording (12-lead) within the normal range
- Clinically normal findings for haematology and clinical chemistry of blood and urine, or showing clinically insignificant deviations only
- Negative screening results (within the 14 days before study start) for drug of abuse, including opiates, cannabinoids, amphetamines, methamphetamine, benzodiazepines and cocaine
- Negative HIV and Hepatitis B and C tests (within the 14 days before study start)
- Appropriate use of an effective method of contraception (female volunteers only)
- Negative pregnancy test (female volunteers only)
- Ability to comprehend and communicate effectively with the Investigator and staff
- Ability to give written informed consent
Exclusion Criteria:
- Illness within 14 days before the start of the study
- Hospitalisation within 3 months before the start of the study (at the discretion of the Investigator)
- Participation in a clinical trial in which blood was taken within 16 weeks before the start of the study
- Participation in a clinical trial in which a volume of blood exceeding 500 ml was taken within 12 months before the start of the study
- Donation of blood or plasma within 90 days before the start of the study
- Any indication of current or previous abuse of alcohol, solvents or drugs
- Treatment with a full or regular course of medication during the 28 days before the start of the study or with any proscribed medication during the 14 days before the start of the study
- Use of alcohol on study days or within 24 hours prior to commencement of each study period
- 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
- Intake of quantities of methylxanthine or alcohol-containing beverages which, in the opinion of the Investigator are abnormal (habitually taking more than 5 cups or glasses of tea, coffee, cola, chocolate etc. per day or habitually taking more than 20 g alcohol/day)
- Patient is pregnant, or lactating/breastfeeding (female volunteers only)
- Diet, which in the opinion of the Investigator, deviates from a normal diet (e.g. vegans)
- Patients who have resided in areas of Africa known to be endemic for Onchocerca volvulus (onchocerciasis or river blindness), wuchereria bancrofti (lymphatic filariasis), Loa loa or other microfilaremic disease
- Patients with a known or suspected intestinal helminth infection, such as Strongyloides stercoralis or other intestinal helminth
- Patients with a known hypersensitivity to any component of the Ivermectin product
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ivermectin
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.
Doses will be administered 20 minutes after a standard breakfast.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic parameters, including AUC0-t, AUC0-inf, and Cmax
Time Frame: 21 samples over 144 hours in each period, with a 14-day washout
|
21 samples over 144 hours in each period, with a 14-day washout
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic parameters, including t1/2, Mean residence time (MRT), Terminal Elimination Rate Constant (kel) and Tmax
Time Frame: 21 samples over 144 hours in each period, with a 14-day washout
|
21 samples over 144 hours in each period, with a 14-day washout
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (ACTUAL)
April 1, 2005
Study Completion (ACTUAL)
April 1, 2005
Study Registration Dates
First Submitted
June 15, 2009
First Submitted That Met QC Criteria
June 15, 2009
First Posted (ESTIMATE)
June 16, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
October 6, 2011
Last Update Submitted That Met QC Criteria
October 4, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCO2804
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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