Ivermectin Solution Bioequivalence Study - Fasted
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.
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
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Conditions
Healthy
Intervention
ivermectin
Location
Shandon Clinic
Cork
Co. Cork
Ireland
Status
Completed
Source
Johnson & Johnson Consumer & Personal Products Worldwide
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00921154
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Ivermectin
A mixture of mostly avermectin H2B1a (RN 71827-03-7) with some avermectin H2B1b (RN 70209-81-3), which are macrolides from STREPTOMYCES avermitilis. It binds glutamate-gated chloride channel to cause increased permeability and hyperpolarization of nerve and muscle cells. It also interacts with other CHLORIDE CHANNELS. It is a broad spectrum antiparasitic that is active against microfilariae of ONCHOCERCA VOLVULUS but not the adult form.
Clinical Trials
Ivermectin Versus Albendazole for Chronic Strongyloidiasis
A prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis wi...
Ivermectin Solution Bioequivalence Study - With Food (Repeat)
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...
Safety and Efficacy of Drug Combinations Against Trichuris Trichiura
This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD eac...
Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation
This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo.
The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.
PubMed Articles
A glycine residue essential for high ivermectin sensitivity in Cys-loop ion channel receptors.
Ivermectin exerts its anthelmintic effect by activating nematode Cys-loop glutamate-gated receptors. Here we show that a glycine residue at a specific transmembrane domain location is essential for hi...
To identify known drugs with previously unrecognized anti-cancer activity, we compiled and screened a library of such compounds to identify agents cytotoxic to leukemia cells. From these screens, we i...
Anthelmintic resistance has emerged globally as a problem amongst nematode of livestock and has been particularly well documented in equine and small ruminants. There are no studies regarding the effi...
Treatment of scabies: Comparison of permethrin 5% versus ivermectin.
Scabies is an ectoparasitic, highly contagious skin disease caused by a mite called Sarcoptes scabiei. The insecticides ivermectin and permethrin are commonly used for treatment of scabies. This study...
Looking at a new putative target for the large spectrum antiparasitic drug ivermectin, we recently showed that avermectin-derived drugs are active against promastigote and amastigote forms of Leishman...
