NCT00921674

Ivermectin Solution Bioequivalence Study - With Food

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 a standard meal. The study is designed in accordance with the EU Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001.

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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. Doses will be administered 20 minutes after a standard breakfast.

Timeline

• Start date: 2005-02-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2009-06-16
• Last updated: 2011-10-06