Ivermectin Solution Bioequivalence Study - With Food

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ivermectin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00921674

SCO2804

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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